orbisphere model 29981 - hach india

Document Number DG29981-MAN/E

ORBISPHERE Model 29981

USER MANUAL

October 2014, Revision F

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Table of Contents

Section 1 General Information ......................................................................................................... 31.1 Disclaimer .................................................................................................................................... 31.2 Contact information...................................................................................................................... 31.3 Safety information ........................................................................................................................ 3

1.3.1 Use of hazard information ................................................................................................... 31.3.2 Service and repairs ............................................................................................................. 31.3.3 Precautionary labels............................................................................................................ 4

1.4 Product recycling information....................................................................................................... 51.5 Product disposal .......................................................................................................................... 7

Section 2 Specifications.................................................................................................................... 92.1 General specifications.................................................................................................................. 9

Section 3 Installation........................................................................................................................ 113.1 Package sampler description..................................................................................................... 113.2 Assembly ................................................................................................................................... 12

3.2.1 Installing the oxygen sensor.............................................................................................. 123.2.2 Installing the analyzer ....................................................................................................... 12

3.3 Connections ............................................................................................................................... 133.3.1 Power ................................................................................................................................ 133.3.2 Purge gas.......................................................................................................................... 133.3.3 Deaerated water connection ............................................................................................. 14

3.4 Calibration.................................................................................................................................. 143.5 Storage when not used .............................................................................................................. 14

Section 4 Operating Instructions .................................................................................................. 154.1 Operating sequences................................................................................................................. 154.2 Package sampler controls.......................................................................................................... 164.3 Preliminary checks and setup .................................................................................................... 16

4.3.1 Check deaerated water dispenser .................................................................................... 164.3.2 Adjust package support to ampoule height ....................................................................... 164.3.3 Needle assembly check .................................................................................................... 164.3.4 Adjust the arm height ........................................................................................................ 174.3.5 Adjust piercing stop height ................................................................................................ 17

4.4 Sampling procedure................................................................................................................... 184.4.1 Procedure for glass ampoules .......................................................................................... 184.4.2 Procedure for vials with a rubber septum.......................................................................... 19

4.5 After use..................................................................................................................................... 19Section 5 Maintenance and Troubleshooting............................................................................. 21

5.1 Maintenance .............................................................................................................................. 215.1.1 Sensor service .................................................................................................................. 215.1.2 Flow chamber servicing .................................................................................................... 215.1.3 Piercing needle replacement............................................................................................. 22

5.2 Troubleshooting ......................................................................................................................... 235.2.1 Using the test unit (model ref. 29872) ............................................................................... 235.2.2 Check for purge gas leaks ................................................................................................ 245.2.3 Unable to purge the system .............................................................................................. 245.2.4 Sudden jet of water ........................................................................................................... 245.2.5 Alternate check for purge gas leaks.................................................................................. 245.2.6 Check for air leaks ............................................................................................................ 245.2.7 Check baselines for oxygen upper limits........................................................................... 255.2.8 Check for water leaks........................................................................................................ 255.2.9 Check oxygen values ........................................................................................................ 255.2.10 Check for clogged needle ............................................................................................... 255.2.11 Unable to obtain low residual value ................................................................................ 265.2.12 Check purge gas shutoff for vials.................................................................................... 26

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Table of Contents

Section 6 Spare Parts .......................................................................................................................27Section 7 Package Support Selection Guide..............................................................................29

7.1 Package supports for ampoules.................................................................................................297.1.1 Package supports for ampoules (Ø 10 to 16.5 mm)..........................................................307.1.2 Package supports for ampoules (Ø 16.5 to 25.5 mm).......................................................317.1.3 Package supports for ampoules (Ø 25.5 to 29 mm)..........................................................32

7.2 Package supports for vials .........................................................................................................337.2.1 Package supports for vials (Ø 12 to 57 mm) .....................................................................34

Section 8 Glossary of Terms ..........................................................................................................358.1 Common units ............................................................................................................................358.2 Terms and definitions .................................................................................................................35

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Section 1 General Information

1.1 DisclaimerThe information in this manual has been carefully checked and is believed to be accurate. However, Hach Lange assumes no responsibility for any inaccuracies that may be contained in this manual. In no event will Hach Lange be liable for direct, indirect, special, incidental, or consequential damages resulting from any defect or omission in this manual, even if advised of the possibility of such damages. In the interest of continued product development, Hach Lange reserves the right to make improvements in this manual and the products it describes at any time, without notice or obligation.

Copyright © 2010-2014 by Hach Lange. All rights reserved. No part of the contents of this manual may be reproduced or transmitted in any form or by any means without the written permission of Hach Lange.

1.2 Contact information

1.3 Safety informationFor safe operation, please read the entire manual before unpacking, setting up, or operating this instrument.

Pay particular attention to all warning and caution statements. Failure to do so could result in serious injury to the operator or damage to the equipment.

To ensure the protection provided by this equipment is not impaired, do not use or install this equipment in any manner other than that which is specified in this manual.

1.3.1 Use of hazard information

WARNINGA warning is used to indicate a condition which, if not met, could cause serious personal injury and/or death. Do not move beyond a warning until all conditions have been met.

CAUTIONA caution is used to indicate a condition which, if not met, could cause minor or moderate personal injury and/or damage to the equipment. Do not move beyond a caution until all conditions have been met.

Note: A note is used to indicate important information or instructions that should be considered before operating the equipment.

1.3.2 Service and repairsNone of the instrument’s components can be serviced by the user. Only personnel from Hach Lange or its approved representative(s) is (are) authorized to attempt repairs to the instrument and only components formally approved by the manufacturer should be used. Any attempt at repairing the instrument in contravention of these principles could cause damage to the instrument and corporal injury to the person carrying out the repair. It renders the warranty null and void and could compromise the correct working of the instrument and the electrical integrity or the CE compliance of the instrument.

If you have any problems with installation, starting, or using the instrument please contact the company that sold it to you. If this is not possible, or if the results of this approach are not satisfactory, please contact the manufacturer’s Customer Service.

Manufacturing site:

HACH LANGE Sàrl6, route de Compois1222 VésenazSWITZERLANDTel. +41 22 594 6400Fax +41 22 594 6499

European HQ:

HACH LANGE GmbHWillstätterstraße 1140549 DüsseldorfGERMANYTel. +49 211 52 880Fax +49 211 52 88143

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General Information

1.3.3 Precautionary labelsRead all labels and tags attached to the instrument. Personal injury or damage to the instrument could occur if not observed.

This symbol, when noted on a product enclosure or barrier, indicates that a risk of electrical shock and/or electrocution exists and indicates that only individuals qualified to work with hazardous voltages should open the enclosure or remove the barrier.

This symbol, when noted on the product, indicates that the marked item can be hot and should not be touched without care.

This symbol, when noted on the product, indicates the presence of devices sensitive to electrostatic discharge and indicates that care must be taken to prevent damage to them.

This symbol, when noted on the product, identifies a risk of chemical harm and indicates that only individuals qualified and trained to work with chemicals should handle chemicals or perform maintenance on chemical delivery systems associated with the equipment.

This symbol, if noted on the product, indicates the need for protective eye wear.

This symbol, when noted on the product, identifies the location of the connection for protective earth (ground).

Electrical equipment marked with this symbol may not be disposed of in European public disposal systems. In conformity with European local and national regulations, European electrical equipment users must now return old or end-of-life equipment to the manufacturer for disposal at no charge to the user.

Products marked with this symbol indicates that the product contains toxic or hazardous substances or elements. The number inside the symbol indicates the environmental protection use period in years.

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General Information

1.4 Product recycling information

ENGLISH

Electrical equipment marked with this symbol may not be disposed of in European public disposal systems after 12 August 2005. In conformity with European local and national regulations (EU Directive 2002/96/EC), European electrical equipment users must now return old or end-of-life equipment to the manufacturer for disposal at no charge to the user.Note: For return for recycling, please contact the equipment manufacturer or supplier for instructions on how to return end-of-life equipment for proper disposal.

DEUTSCH

Elektrogeräte, die mit diesem Symbol gekennzeichnet sind, dürfen in Europa nach dem 12. August 2005 nicht mehr über die öffentliche Abfallentsorgung entsorgt werden. In Übereinstimmung mit lokalen und nationalen europäischen Bestimmungen (EU-Richtlinie 2002/96/EC), müssen Benutzer von Elektrogeräten in Europa ab diesem Zeitpunkt alte bzw. zu verschrottende Geräte zur Entsorgung kostenfrei an den Hersteller zurückgeben.Hinweis: Bitte wenden Sie sich an den Hersteller bzw. an den Händler, von dem Sie das Gerät bezogen haben, um Informationen zur Rückgabe des Altgeräts zur ordnungsgemäßen Entsorgung zu erhalten.

FRANCAIS

A partir du 12 août 2005, il est interdit de mettre au rebut le matériel électrique marqué de ce symbole par les voies habituelles de déchetterie publique. Conformément à la réglementation européenne (directive UE 2002/96/EC), les utilisateurs de matériel électrique en Europe doivent désormais retourner le matériel usé ou périmé au fabricant pour élimination, sans frais pour l'utilisateur.Remarque: Veuillez vous adresser au fabricant ou au fournisseur du matériel pour les instructions de retour du matériel usé ou périmé aux fins d'élimination conforme.

ITALIANO

Le apparecchiature elettriche con apposto questo simbolo non possono essere smaltite nelle discariche pubbliche europee successivamente al 12 agosto 2005. In conformità alle normative europee locali e nazionali (Direttiva UE 2002/96/EC), gli utilizzatori europei di apparecchiature elettriche devono restituire al produttore le apparecchiature vecchie o a fine vita per lo smaltimento senza alcun costo a carico dell’utilizzatore.Nota: Per conoscere le modalità di restituzione delle apparecchiature a fine vita da riciclare, contattare il produttore o il fornitore dell’apparecchiatura per un corretto smaltimento.

DANSK

Elektriske apparater, der er mærket med dette symbol, må ikke bortskaffes i europæiske offentlige affaldssystemer efter den 12. august 2005. I henhold til europæiske lokale og nationale regler (EU-direktiv 2002/96/EF) skal europæiske brugere af elektriske apparater nu returnere gamle eller udtjente apparater til producenten med henblik på bortskaffelse uden omkostninger for brugeren.Bemærk: I forbindelse med returnering til genbrug skal du kontakte producenten eller leverandøren af apparatet for at få instruktioner om, hvordan udtjente apparater bortskaffes korrekt.

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General Information

SVENSKA

Elektronikutrustning som är märkt med denna symbol kanske inte kan lämnas in på europeiska offentliga sopstationer efter 2005-08-12. Enligt europeiska lokala och nationella föreskrifter (EU-direktiv 2002/96/EC) måste användare av elektronikutrustning i Europa nu återlämna gammal eller utrangerad utrustning till tillverkaren för kassering utan kostnad för användaren. Obs! Om du ska återlämna utrustning för återvinning ska du kontakta tillverkaren av utrustningen eller återförsäljaren för att få anvisningar om hur du återlämnar kasserad utrustning för att den ska bortskaffas på rätt sätt.

ESPANOL

A partir del 12 de agosto de 2005, los equipos eléctricos que lleven este símbolo no deberán ser desechados en los puntos limpios europeos. De conformidad con las normativas europeas locales y nacionales (Directiva de la UE 2002/96/EC), a partir de esa fecha, los usuarios europeos de equipos eléctricos deberán devolver los equipos usados u obsoletos al fabricante de los mismos para su reciclado, sin coste alguno para el usuario. Nota: Sírvase ponerse en contacto con el fabricante o proveedor de los equipos para solicitar instrucciones sobre cómo devolver los equipos obsoletos para su correcto reciclado.

NEDERLANDS

Elektrische apparatuur die is voorzien van dit symbool mag na 12 augustus 2005 niet meer worden afgevoerd naar Europese openbare afvalsystemen. Conform Europese lokale en nationale wetgegeving (EU-richtlijn 2002/96/EC) dienen gebruikers van elektrische apparaten voortaan hun oude of afgedankte apparatuur kosteloos voor recycling of vernietiging naar de producent terug te brengen.Nota: Als u apparatuur voor recycling terugbrengt, moet u contact opnemen met de producent of leverancier voor instructies voor het terugbrengen van de afgedankte apparatuur voor een juiste verwerking.

POLSKI

Sprzęt elektryczny oznaczony takim symbolem nie może być likwidowany w europejskich systemach utylizacji po dniu 12 sierpnia 2005. Zgodnie z europejskimi, lokalnymi i państwowymi przepisami prawa (Dyrektywa Unii Europejskiej 2002/96/EC), użytkownicy sprzętu elektrycznego w Europie muszą obecie przekazywać Producentowi stary sprzęt lub sprzęt po okresie użytkowania do bezpłatnej utylizacji.Uwaga: Aby przekazać sprzęt do recyklingu, należy zwrócić się do producenta lub dostawcy sprzętu w celu uzyskania instrukcji dotyczących procedur przekazywania do utylizacji sprzętu po okresie użytkownia.

PORTUGUES

Qualquer equipamento eléctrico que ostente este símbolo não poderá ser eliminado através dos sistemas públicos europeus de tratamento de resíduos sólidos a partir de 12 de Agosto de 2005. De acordo com as normas locais e europeias (Directiva Europeia 2002/96/EC), os utilizadores europeus de equipamentos eléctricos deverão agora devolver os seus equipamentos velhos ou em fim de vida ao produtor para o respectivo tratamento sem quaisquer custos para o utilizador.Nota: No que toca à devolução para reciclagem, por favor, contacte o produtor ou fornecedor do equipamento para instruções de devolução de equipamento em fim de vida para a sua correcta eliminação.

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General Information

1.5 Product disposalNote: The following only applies to European customers.

Hach Lange is committed to ensuring that the risk of any environmental damage or pollution caused by any of its products is minimized as far as possible. The European Waste Electrical and Electronic Equipment (WEEE) Directive (2002/96/EC) that came into force on August 13 2005 aims to reduce the waste arising from electrical and electronic equipment; and improve the environmental performance of all those involved in the life cycle of electrical and electronic equipment.

In conformity with European local and national regulations (EU Directive 2002/96/EC stated above), electrical equipment marked with the above symbol may not be disposed of in European public disposal systems after 12 August 2005.

Hach Lange will offer to take back (free of charge to the customer) any old, unserviceable or redundant analyzers and systems which carry the above symbol, and which were originally supplied by Hach Lange. Hach Lange will then be responsible for the disposal of this equipment.

In addition, Hach Lange will offer to take back (at cost to the customer) any old, unserviceable or redundant analyzers and systems which do not carry the above symbol, but which were originally supplied by Hach Lange. Hach Lange will then be responsible for the disposal of this equipment.

Should you wish to arrange for the disposal of any piece of equipment originally supplied by Hach Lange, please contact your supplier or our After Sales Service department in Geneva for instructions on how to return this equipment for proper disposal.

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General Information

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Section 2 Specifications

Specifications are subject to change without notice.

Note: Detailed specifications for the analyzer and sensor can be found in their related operator manual.

2.1 General specifications

SAMPLER

Purge gas Nitrogen, 99.99% purity 0.1 to .03 bar pressure

Connection for purge gas Swagelok® for 6mm ext

Dimensions (H x W x D) 470 x 148 x 212 mm (including flow chamber)

Material Eloxed aluminum

Power requirements 110/240 VAC ± 10% @50/60 Hz external transformer

Weight 3.9 kg

Water dispenser 0.1 to 1.0 mL injection volume, 250 mL bottle capacity

EMC requirements This product is intended to be used in a domestic or basic electromagnetic environment

PERFORMANCE

Measuring range 0.05% to 21% volume O2

Analysis time < 60 sec (membrane 2956A)

Accuracy ± 1% of reading or ± 0.01% volume O2 whichever is greater

Repeatability r95 = ± 0.08% O2

Temperature compensation 0 to 50°C

PACKAGE SUPPORTS

Ampoules Model 29870.xx from 1 mL up to 50 mL (Ø 10 mm to 29 mm)

Vials Model 2987.xx.xxx from Ø 12mm to 57 mm

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Specifications

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Section 3 Installation

3.1 Package sampler descriptionThe PharmaPack can analyze volumes as small as one milliliter, in ampoules and vials. The oxygen sensor makes headspace gas measurements and sends them to the analyzer for display. The package sampler is operator controlled. Position of the sample platform controls the flow of purge gas.

When the package moves up, the piercing needle assembly is pressed up against the bottom of the flow chamber, thus blocking purge gas flow by compressing the inner O-ring. Note the difference in the space and the compression of the O-rings between the flow chamber and the needle assembly.

Subsequently, when deaerated water is dispensed into the package, the headspace gas is forced up the inner needle, and into the flow chamber.

The arm (5) supports the oxygen sensor, the flow chamber, and the piercing needle assembly. A black handle (6), located at the rear of this arm, allows for height adjustment to fit the package size.

The motorized sample holding platform (3) moves up and down, controlled by the toggle switch (2) on the front panel. When the toggle switch is lifted, the platform stops automatically at a preset level. This is set by the adjustable red lever (7), located behind the piercing needle. When the toggle switch is lowered, the platform stops automatically at a factory preset level.

Two indicator lights are located on the front panel. A red light (8) illuminates when the power is turned on (switch on the back panel). The light (1), at the side of the toggle switch, is orange as the sample platform is raised, turns to green when the platform is lowered, and is off when the platform stops.

The oxygen sensor is mounted into the top of the flow chamber and the piercing needle assembly is attached to the bottom of the flow chamber.

A purge gas connection is located on the flow chamber side. An outlet tube (4) is connected to a small glass bubbler secured in a plastic holder, and which allows a visual check of the purge gas flow.

A deaerated water dispenser (not shown) is used for forcing the headspace volume into the flow chamber for measurement. This dispenser is connected by flexible tubing to the piercing needle assembly.

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Installation

3.2 Assembly

3.2.1 Installing the oxygen sensorShipping conditions can adversely affect oxygen sensors. Before measuring with the package sampler system, you should perform a sensor service, as described in the sensor maintenance manual, and a sensor calibration (follow instructions in the Operator Manual of the analyzer installed with the PharmaPack).

If you do not intend to use the system within two weeks of delivery, remove the oxygen sensor from the flow chamber. Then clean and store the sensor, as instructed in the sensor maintenance manual.

The oxygen sensor is shipped separately from the package sampler and must be installed at the user location. It is shipped with a plastic screw-on storage cap covering the sensor cell, and a plastic screw-on base protecting the connector. Remove both the storage cap and base from the sensor and store them safely.

Place a thin film of silicone grease on the O-ring inside the flow chamber. This will help to get a better seal. Insert the sensor straight into the flow chamber. Hold the sensor body to prevent twisting, and screw the sensor collar hand tight.

To remove the sensor, when required for sensor service or storage, carefully unscrew the sensor collar and lift the sensor straight out of the flow chamber.

3.2.2 Installing the analyzerLocate the analyzer conveniently close to the power source, the package sampler and your PC (where applicable). Please refer to the analyzer operator’s manual for full installation details.

Figure 1 Oxygen sensor installation diagram

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Installation

3.3 Connections

3.3.1 PowerAn external power supply (transformer) provides a regulated DC of 24V to the instrument. The transformer itself operates from 100 VAC up to 240 VAC.

3.3.2 Purge gas A user-supplied source of oxygen-free nitrogen (99.99% pure) is required for purging the flow chamber before each measurement. Connect the purge gas supply to the Swagelok fitting on the side of the sampler arm

Place a two-stage gas pressure regulator (user-supplied) suitable for pressures <1 bar. Install it between the purge gas supply and the package sampler. Place a user supplied needle valve between the regulator and the package sampler, as close to the sampler as is practical, to provide a precise gas flow adjustment.

Use a low oxygen permeability flexible tubing to connect the gas to the regulator (Nylon is recommended), since the purge gas may stay in this tubing for several hours before reaching the sensor.

Note: When you first operate the system, it is important to flush out as much oxygen as possible from the measuring chamber. Before initial measurements or after a sensor service, run the purge gas through the measuring chamber until the baseline corresponding to your application is reached (see Table 1 below).

Connect a length of flexible tubing (supplied) from the purge gas exit port on the flow chamber to the glass bubbler (as illustrated).

Ensure there is enough water in the bubbler and refill if necessary up to the line on the bubbler marked -Max-.

Adjust the purge gas supply at 0.5 bar. The user supplied needle valve provides the final micro adjustment needed for a very low flow rate.

Check the flow rate in the bubbler and verify that 2-3 bubbles appear each second.

Table 1 Recommended baselines

Expected Oxygen Level Maximum Baseline Value

5% 0.250% (kPa)

4% 0.200% (kPa)

3% 0.150% (kPa)

2% 0.100% (kPa)

1% 0.05% (kPa)

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Installation

3.3.3 Deaerated water connectionA deaerated water dispenser provides water to push air out of the tubing, and to push the headspace volume out of the ampoule or the vial. Using plastic tubing, connect the dispenser of deaerated water to the lateral connection located near the bottom of the piercing needle assembly.

Set the dispenser to deliver 1 mL of water with each shot.

3.4 CalibrationThe PharmaPack instrument itself cannot be calibrated, but you should calibrate the oxygen sensor on a regular basis (at least once every 3 months), and after every sensor service. This can be done easily and accurately in humid air.

For full instructions on the calibration process, refer to the relevant section in the analyzer Operator Manual delivered with your system.

3.5 Storage when not usedIf you plan an inactive period of more than two weeks, remove the oxygen sensor from the flow chamber (see sensor maintenance manual for details), and store it in the calibration cap.

If you expect not to use your PharmaPack for more than one month, clean and store the sensor (see sensor maintenance manual for details).

Figure 2 Model 29981 Connections

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Section 4 Operating Instructions

4.1 Operating sequencesThe following flow chart shows the basic measurement sequence for the PharmaPack headspace oxygen analyzer.

Figure 3 Measurement Sequence

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Operating Instructions

4.2 Package sampler controlsThe operator controls of the package sampler are as follows :

1. Black height adjustment handle: Adjusts movable arm and piercing needle assembly height.

2. Toggle switch: Moves sample platform up or down. When moving up, the platform is stopped automatically by the red lever behind the piercing needle.

3. Movement indicating light: Orange as the platform moves up, green as the platform moves down, and off when the platform is not moving.

4.3 Preliminary checks and setup

4.3.1 Check deaerated water dispenser

4.3.2 Adjust package support to ampoule height

4.3.3 Needle assembly check Check that correct needle assembly is used. The package sampler uses two different piercing needles, one is for piercing ampoules and one for piercing vials. If you use both, you must use the correct piercing needle assembly each time.

The piercing needle assembly for ampoules (ref. 280582) has a black knurled collar, while the piercing needle assembly for vials (ref. 280583) has a grey knurled collar.

Note: If you experience difficulty in piercing sample vials or ampoules, if the piercing needle is shattering the glass ampoules, or if the piercing needle is clogged, the needle must be changed (see Piercing needle replacement on page 22).

Check that sufficient deaerated water is available in the dispenser before starting a measurement session.

For better results, make sure there are no air bubbles trapped in the tube attached to the PharmaPack.

Check the amount of water to be delivered with each shot is set correctly (the recommended quantity is 1mL).

If you purchased the model 28300 ORBISPHERE dispenser with your PharmaPack, lift the plunger to ensure it dispenses water correctly (no air bubbles) and returns automatically to the closed position. You may need to do this a few times until the plunger returns smoothly to the start position.

To adjust the ampoule package support to the height of the ampoule, place an ampoule inside the package support, with the flat end of the ampoule in the smaller (top) part of the support. Screw support together, finger-tight.

To adjust height, turn the Allen screw on the bottom of the package support (top picture) until the flat end of the glass ampoule is even with the top surface of the support (bottom picture).

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4.3.4 Adjust the arm height

4.3.5 Adjust piercing stop height

• For ampoules: When the top of the cutting edge of the needle is level with the top of the empty package support, stop the platform move by switching to "off".

• For vials: When the needle start to pierce the septum of the vial, stop the platform move by switching to "off".

Loosen the Allen screw on the side of the red lever (located on vertical post behind needle, see photo above). Adjust the red lever until it just touches the top of the package support. Then, tighten the Allen screw. Reinstall the needle rubber seal.

Note: The travel and stop adjustment of this lever is critical! There will be an insufficient seal if the rubber gasket is compressed too much, and air may get in leading to errors.

If proper sealing cannot be achieved with the adjustment above, replace the needle rubber gasket. Lower the sample platform, remove and install the new rubber gasket around the needle.

Lower the sample platform all the way and remove the rubber seal from the piercing needle.

Place a package support on the sample platform.

• For ampoules: Leave the ampoule support empty, with both parts screwed tightly together.

• For vials: Place a sample vial into the package support.

Loosen the black handle and adjust height of arm until the needle is 2 cm above the top of the ampoule package support (top photo) or the vial septum (bottom photo). Then, tighten the black handle.

When the toggle switch is raised to the "up" position, the platform is lifted and stops automatically at a preset height. This level is set by the position of the red lever, located behind the piercing needle :

Move the toggle switch to "up".

Note: Watch the piercing needle position carefully!

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4.4 Sampling procedure

4.4.1 Procedure for glass ampoules

Setup

1. Switch the analyzer into "Measure" mode (refer to the analyzer operator's manual for detailed instructions).

2. Start the flow of purge gas from a cylinder of pure nitrogen (user supplied). Adjust the gas pressure, via the two stage regulator (see Purge gas on page 13). Check the flow rate in the glass bubbler, and verify that 2-3 bubbles appear each second.

3. Purge the flow chamber until the reading on the analyzer is very low (<0.10%).

4. Before performing the first measurement, check that no air is present in the water tube or in the piercing needle assembly. To do this, first place a beaker under the piercing needle assembly to collect water from the needle. Then, from the deaerated water dispenser, send 1 mL (one shot) through the water tube and piercing needle into the beaker.

Measurement

3. Place the package support on the sample platform with the exposed end of the ampoule up.

4. Send 1 mL of deaerated water through the piercing needle assembly, onto the exposed end of the ampoule in the package support. This water removes any air trapped between the ampoule surface and the sampling system.

5. Move the toggle switch on the front of the sampler base to the "up" position. The indicator light turns orange.

6. The sampling platform moves up and stops automatically at the correct level after piercing the ampoule. The purge gas shuts off automatically just before the needle pierces the ampoule (no gas bubbles should appear in the glass bubbler).

7. From the dispenser, send 1 mL of deaerated water through the piercing needle, and into the ampoule. Watch for bubbles in the glass bubbler.

Note 1: For a headspace larger than 1 mL, adjust the water dispenser to deliver a quantity of deaerated water close to (but not exceeding) the headspace volume.

Note 2: If too much water is sent into the ampoule, liquid from the ampoule itself is forced through the flow chamber. This may block the path of the gas, resulting in slow response of sensor. If this problem occurs, install the test unit empty and raise the platform. Quickly deliver several shots of deaerated water into the test unit. The flow chamber will be dried. Check for low readings.

Note: The piercing needle assembly for vials has a grey knurled collar, while the piercing needle assembly for ampoules has a black collar. The rubber gasket used for vials is a cylindrical gasket (left piece in photo), while the H-shaped rubber gasket is used for glass ampoules (right piece in photo).

1. Wet the inside of the two-part package support and place the sample ampoule inside. Flat end of the ampoule must be flush with the flat end of the smaller piece of the support. To insure proper placement, put the support on a table and insert the ampoule carefully. Screw the support together, finger-tight.

2. Scribe a 3 mm circle on the exposed flat end of the ampoule with the diamond tip pencil provided. If you do not do this, the mechanical shock of piercing the ampoule could introduce sufficient air to generate a false reading.

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8. Once the signal on the analyzer display peaks, record the value. The signal will increase at first, and then stabilize. You should record the value at the end of the increase slope, right at the beginning of stabilization.

9. Move the toggle switch down. The indicator light turns green. The sampling platform is lowered and stops automatically.

10. Remove the package support and unscrew the two parts.

11. With a pencil, carefully push the ampoule out of the support.

12. Rinse and wipe the support with a paper tissue.

CAUTIONBeware of any glass debris ! The possible presence of small piece of glass could cut your finger !

Note 1: Occasionally, wipe the rubber gasket of the piercing needle with a dry, clean, thick tissue (not with your fingers, because of the danger caused by small pieces of glass).

Note 2: To completely dry out any moisture that may remain, open the purge gas for 30 seconds before sampling next package.

4.4.2 Procedure for vials with a rubber septumThe procedure is the same as for glass ampoules, except the following differences:

4.5 After useAt least once a week, or after a spill of liquid, clean the supporting bars of the sample platform and the base of the platform with a wet tissue. Then dry with a dry tissue and lightly grease with the silicon grease provided.

If you use your PharmaPack every day, do one of the following at the end of the day to help the sensor avoid contact with high oxygen levels:

• Keep the purge gas supply running through the flow chamber past the sensor, and switch off the analyzer.

• Alternatively, if the above method is impractical, fill the test unit with water, raise the base of the package sampler until the test unit makes contact with the rubber stopper, and then switch off the analyzer.

The package supports for vials are one piece. Place the vial, with septum up, into the package support.

Note: There is no preparation needed, just let the needle pierce the rubber septum of the vial. There is no need to wet the septum surface before piercing

20


21

Section 5 Maintenance and Troubleshooting

5.1 Maintenance

5.1.1 Sensor serviceYou will know it is time to perform an oxygen sensor service when you experience:

• Difficulties with calibration

• An unusually long stabilization time

• Noisy or drifting signals under a constant oxygen concentration situation

Note: See sensor’s maintenance manual for details on servicing procedure.

Once the sensor has been serviced, give the membrane 30 minutes to relax before performing a calibration (as mentioned in Calibration on page 14). Once the sensor is calibrated, it can be installed in the PharmaPack flow chamber (see Installing the oxygen sensor on page 12).

5.1.2 Flow chamber servicingClean the flow chamber periodically to ensure proper operation. Depending on its use, you should do this every six to twelve months.

RemovalTo remove the flow chamber:

InstallationTo re-install the flow chamber:

1. Place the flow chamber into the arm of the package sampler. Screw on the flow chamber black ring from below the arm, using the metal wrench (illustrated below) provided in the sensor recharge kit.

1. Close the purge gas source. Disconnect the deaerated water supply from the piercing needle assembly.

2. Carefully unscrew the sensor collar and pull the sensor straight out of the flow chamber.

3. Remove the piercing needle from the flow chamber by unscrewing the knurled ring with your fingers.

4. Unscrew the flow chamber black holding collar (located below the arm) by hand, or using the small wrench (illustrated) provided in any sensor recharge kit.

5. Remove the flow chamber from the arm of the package sampler. Remove and discard the O-ring located inside the flow chamber.

6. Rinse the flow chamber with water, and then blow out all orifices with clean compressed air.

7. Replace the O-ring (kit ref. 32916). Lightly grease the O-ring with a thin film of silicone grease when placing it into the flow chamber.

Note: Do not confuse the flow chamber O-ring with the O-ring for the sensor head. They look similar but they are not.

22

Maintenance and Troubleshooting

2. Insert the sensor straight into the flow chamber. Hold the sensor body to prevent twisting, and screw on the sensor collar, hand tight.

3. Before installing the piercing needle assembly, discard the small O-ring in the middle of the assembly, and replace with a new one (kit ref. 32916).

4. Lightly lubricate the O-ring with silicone grease. Then, screw the piercing needle into the bottom of the flow chamber, hand tight using the knurled ring.

5. Reconnect the purge gas and deaerated water supplies.

5.1.3 Piercing needle replacementIf the following difficulties are experienced, the needle must be changed:

• Difficulty to pierce glass or rubber septum

• Piercing needle is shattering the glass ampoules

• Piercing needle is clogged

The package sampler uses two different piercing needles, one is for piercing ampoules and has a black knurled collar, and one for piercing vials which has a grey knurled collar. If you use both, make sure to use the correct piercing needle assembly for each situation.

RemovalTo remove the piercing needle assembly:

1. Close the purge gas source.

2. Disconnect the deaerated water supply from the needle assembly.

3. Remove the rubber gasket from around the needle.

4. Gently, unscrew the piercing needle assembly counterclockwise from the flow chamber by turning the knurled metal collar of the assembly with your fingers. When you remove the needle assembly, make sure to remove its outer O-ring from the flow chamber (it may stick inside the flow chamber).

Installation

5. Turn on the purge gas and verify the presence of bubbles in the glass bubbler. The signal on the analyzer’s display should decrease.

6. Check the internal purge gas valve by pushing the piercing needle assembly firmly up with your fingers (not by the rubber seal). Bubbles should stop appearing in the glass bubbler.

7. Check the stop position of the piercing needle assembly (see Adjust piercing stop height on page 17).

1. First, lightly lubricate both the outer O-ring and the small O-ring in the middle of the assembly with silicon grease. When replacing these O-rings, make sure that no dust or particles are present.

2. Screw the piercing needle assembly into the bottom of the flow chamber, finger tight using the knurled collar.

3. Reconnect the deaerated water dispenser and inject water from the dispenser to flush gas from the piercing needle assembly.

4. Place the appropriate rubber seal over the needle. The cylindrical gasket (on the left) is for vials sealed with a rubber septum. The H-shaped seal (on the right) is for glass ampoules.

23


5.2 TroubleshootingRefer to the diagram below for illustration of the purge gas, deaerated water, and sample gas flows. Use these drawings in support of the following troubleshooting tests. The analyzer must be connected and operating for most of these tests.

5.2.1 Using the test unit (model ref. 29872)

Figure 4 Before and after piercing sequences

The test unit (illustrated) allows for a variety of tests without having to pierce actual vials or ampoules.

A purge gas inlet is situated at the bottom of the unit, with the outlet at the top.

24


5.2.2 Check for purge gas leaksTo test for purge gas leaks, place a beaker of water on the sample platform. Then raise the platform so that the needle is immersed in the water (but the beaker is not pressing on the needle or gasket).

Start the purge gas and regulate the purge gas pressure to slightly more than atmospheric pressure.

When the purge gas is on, bubbles should be visible in the glass bubbler, and from the needle in the beaker. However, when the purge gas is off, the bubbling should stop.

The analyzer display should show a change of no more than 0.01 kPa per minute, otherwise a leak may be present and you should check all fittings.

5.2.3 Unable to purge the systemIf you observe no bubbles when the purge gas is on during the preceding test, check to see if either the piercing needle assembly is too tight or the sensor is improperly mounted on the flow chamber.

5.2.4 Sudden jet of waterA sudden jet of water can come out of the purge gas exit tubing if the purge gas pressure is too high. Excessive purge gas pressure can cause gas to leak into the flow chamber during the measuring phase, thus distorting readings. Adjust purge gas pressure and flow rate.

5.2.5 Alternate check for purge gas leaks The display value could also decrease in the preceding test if there is leakage of purge gas into the flow chamber. First, verify the presence of bubbles in the glass bubbler.

Then, place the test unit on the sample platform and raise the platform until the rubber gasket forms a seal with the test unit. Check to see that the bubbling stops.

If the bubbling does not stop, the leak is continuous. Disassemble the piercing needle assembly (see Piercing needle replacement on page 22), and replace the small O-ring. Do not forget to place a thin film of silicone grease around the O-rings before reassembling the piercing needle assembly.

If the purge gas tubing "burps", the leak is probably due to purge gas pressure that is too high. Adjust the purge gas pressure and flow rate.

5.2.6 Check for air leaksIf you suspect an air leak somewhere in the flow, first make sure that your purge gas supply is running, and that your sensor is at "baseline", that is, showing a typically low oxygen value. See Table 1 on page 13 if you are unsure of a proper baseline for your product.

• Fill the test unit with deaerated water, full enough to form a protruding meniscus at the test unit's opening.

• Place the test unit on the sample platform and raise the test unit. When the rubber gasket forms a seal with the test unit, stop the platform.

After five minutes, check the analyzer measurement. The oxygen value should remain constant, rising no more than 0.05% (kPa) during that delay. If the value increases significantly, then you may assume that the system is leaking. Check all appropriate fittings and try this test again.

25


5.2.7 Check baselines for oxygen upper limitsIf you suspect a residual value "error", note that the value is always positive. Thus if your sample result is below your upper limit, you can be assured that your system is operating normally. However, if the value displayed is above your upper limit, check the recommended baseline values given in Table 1 on page 13.

5.2.8 Check for water leaksConnect a source of high purity N2 with a known concentration of O2 to a needle to pierce the test units rubber septum. Use N2 with a concentration of O2 close to the concentration that you will want to measure. Insert the needle into the rubber septum, which is located near the bottom of the test unit

Place the test unit on the sample platform and raise the platform until the rubber gasket forms a seal with the test unit. Check if the analyzer measurement corresponds with the known concentration of O2 in the gas.

Then, remove the needle from the test unit and check the measurement display. If the reading decreases with the removal of the needle, water is probably trapped in the flow chamber.

Purge the system with more N2 and repeat the reading. If the decreasing reading persists, indicating that the flow chamber has not dried out, remove the sensor from the flow chamber and carefully dry the sensor face with a clean cloth.

5.2.9 Check oxygen valuesConnect an oxygen supply to a regulator and a needle to pierce the test unit's rubber septum. Use a supply of known O2 content, preferably of a value that closely matches your expected sample oxygen level, for example, 97% N2, 3% O2, to match a 3% expected sample value. You also may wish to install a three way valve ahead of the regulator to allow for alternate gas sources.

Insert the needle into the rubber septum located near the bottom of the test unit. Place the test unit on the sample platform, and run enough gas to purge the test unit cavity.

Then, raise the sample platform. As the test unit approaches the rubber gasket, drop the flow of gas to a trickle (0.01 to 0.03 bar) just before it makes contact. After the rubber gasket forms a seal with the test unit, the glass bubbler should show a few bubbles per second. Check if the analyzer measurement value matches the gas sample.

5.2.10 Check for clogged needle

Fill a small container with soapy water and place on top of the test unit.

With the purge gas running, place the test unit (with the container on top) on the sample platform.

Raise the test unit so that the needle is immersed in the soapy water but ensuring that the container does not come into contact with the needle assembly.

Check for bubbles at the needle (as indicated in the illustration). If bubbles show in the glass bubbler but not from the needle in the container, then the needle may be clogged.

26


5.2.11 Unable to obtain low residual valueIf you have performed all the checks above and there are no air or water leaks, and you are still having problems in obtaining a low residual value, your sensor may need servicing (see sensor maintenance manual).

5.2.12 Check purge gas shutoff for vialsVials have different piercing characteristics, because of the septum shape and its material. These differences may require adjustment to the rubber gasket surrounding the piercing needle. When a sample vial is raised by the platform, two actions occur (see Figure 4 on page 23):

1. The vial is applied against the rubber gasket that surrounds the needle. This action pushes up the piercing needle assembly against the flow chamber, and stops the flow of purge gas to the flow chamber by compressing the inner O-ring. Purge gas flow is indicated by bubbles in the glass bubbler. When the purge gas stops, there are no more bubbles.

2. The needle starts piercing the rubber septum of the vial.

For proper headspace gas measurements, the purge gas must stop flowing before the needle pierces the septum of the vial. You may need to adjust the height of the rubber gasket (shorten or lengthen it) to assure that the purge gas flow stops right before the septum is pierced.

27

Section 6 Spare Parts

Part N° Description

28040 Rubber gaskets for ampoules up to 30 mL (5 pcs.) outer diameter: 28 mm

28042 Rubber gaskets for vials (5 pcs.) outer diameter: 12 mm

28300 Water dispenser for 29981 package sampler

28301 Diamond pencil for 29981 package sampler

28302 Allen key 2.5 mm for 29981 package sampler

28303 Allen key 10 mm for 29981 package sampler

28304 Fuse for 29981 package sampler

29872 Test unit for detecting leaks for 29981 package sampler

32017 Flow chamber for 29981 package sampler

32916 Set of O-rings for flow chamber and piercing needle, for 29981 sampler

32917 Purge gas outlet tubing, 30 cm, for 29981 package sampler

32919 Spare part kit and tool for 29981 package sampler(includes 28042, 28301, 28302, 28303, 32916, 32917)

280582 Piercing needle assembly (black) and O-rings, for piercing ampoules

280583 Piercing needle assembly (grey) and O-rings, for piercing vials

29089S6 Pressure reducer and regulator Kit. For 6mm external tubing

29870.xx Package supports for ampoules Suffixes ".xx", see Package Support Selection Guide on page 29

29871.xx.xxx Package supports for vials Suffixes ".xx.xxx", see Package Support Selection Guide on page 29

31110A.02 Oxygen sensor for 29981 sampler

32809.MM 6 x 4 mm plastic tubing (per meter). MM=specify total length

28

Spare Parts

29

Section 7 Package Support Selection Guide

7.1 Package supports for ampoulesThe tables on the following pages enable you to select the appropriate ORBISPHERE package support based upon your ampoule size. If you cannot match your ampoule size with one of the available supports listed in these tables, then a customized package support will be required.

Determine the following four dimensions of your ampoule and then use the accompanying tables to find out which package support you need.

Package Support Required:

Note: If you need a spare rubber gasket for your package support, use the rubber gasket model number corresponding to your package support model number as identified in the tables on the following pages.

D= mm Use this value to identify the correct package support group. Select the group corresponding to your measured ampoule diameter. This value must fall within the range given by the table.

l = mm Use this value to identify the suitable shoulder adjustable seat for the ampoule body. This value must fall within the range given in the table for each package support.

d = mm This value identifies the appropriate central hole for the ampoule cap. Your measured diameter must be smaller than the maximum value for the support group.

L = mm This value must be smaller than the maximum ampoule length for the support group.

Model 29870. __ __ This is the Package Support Model Number to order, based upon the above parameters and the tables on the following pages.

30

Package Support Selection Guide

7.1.1 Package supports for ampoules (Ø 10 to 16.5 mm)

RUBBER GASKET Model Number Ampoule Dimensions in mm

Package support

model N°

00 4

0081

5-R

00 4

0089

2-R

00 4

0089

1-R

00 4

0081

000

400

890-

R00

400

889-

R00

400

888-

R00

400

809

00 4

0088

7-R

00 4

0088

6-R

00 4

0081

300

400

808-

R00

400

885

Ø D

(ran

ge)

l(ran

ge)

Ø d

(max

)

L(m

ax)

29870.01 10.00-10.50 23.0-33.029870.02 33.0-43.029870.03 10.50-11.00 22.0-32.029870.04 32.0-42.029870.05 11.00-11.50 21.0-31.0 8.7029870.06 31.0-41.029870.07 11.50-12.00 21.0-31.029870.08 31.0-41.029870.09 12.00-12.50 21.0-31.029870.10 31.0-41.029870.11 24.0-34.0 8.7029870.12 12.50-13.00 10.9029870.13 34.0-44.0 8.7029870.14 10.9029870.15 24.0-34.0 8.7029870.16 13.00-13.50 10.9029870.17 34.0-44.0 8.7029870.18 10.90 80.029870.19 23.5-33.5 8.7029870.20 13.50-14.00 10.9029870.21 33.5-43.5 8.7029870.22 10.9029870.23 23.5-33.5 8.7029870.24 14.00-14.50 10.9029870.25 33.5-43.5 8.7029870.26 10.9029870.27 23.0-33.0 8.7029870.28 14.50-15.00 10.9029870.29 33.0-43.0 8.7029870.30 10.9029870.31 15.00-15.50 23.0-33.029870.32 33.0-43.029870.33 15.50-16.00 22.5-32.5 10.9029870.34 32.5-42.529870.35 16.00-16.50 22.5-32.529870.36 32.5-42.5

31


7.1.2 Package supports for ampoules (Ø 16.5 to 25.5 mm)


Package support

model N°

00 4

0091

1-R

00 4

0091

000

400

909-

R00

400

908-

R00

400

907-

R00

400

906-

R00

400

905

00 4

0090

4-R

00 4

0090

3-R

00 4

0090

2-R

00 4

0090

1-R

00 4

0090

000

400

899-

R00

400

898-

R00

400

897-

R00

400

811-

R00

400

896-

R00

400

895

Ø D

(ran

ge)

l(ran

ge)

Ø d

(max

)

L(m

ax)

29870.37 16.50-17.00 56.0-96.029870.38 68.0-108.029870.39 17.00-17.50 55.0-95.029870.40 67.0-107.029870.41 17.50-18.00 55.0-95.029870.42 67.0-107.029870.43 18.00-18.50 55.0-95.029870.44 67.0-107.029870.45 18.50-19.00 54.5-94.529870.46 66.5-106.529870.47 19.00-19.50 54.5-94.529870.48 66.5-106.529870.49 19.50-20.00 54.0-94.029870.50 66.0-106.029870.51 20.00-20.50 54.0-94.029870.52 66.0-106.029870.53 20.50-21.00 53.5-93.5 14.90 145.029870.54 65.5-105.529870.55 21.00-21.50 53.5-93.529870.56 65.5-105.529870.57 21.50-22.00 53.0-93.029870.58 65.0-105.029870.59 22.00-22.50 53.0-93.029870.60 65.0-105.029870.61 22.50-23.00 52.5-92.529870.62 64.5-104.529870.63 23.00-23.50 52.5-92.529870.64 64.5-104.529870.65 23.50-24.00 52.0-92.029870.66 64.0-104.029870.67 24.00-24.50 52.0-92.029870.68 64.0-104.029870.69 24.50-25.00 51.5-91.529870.70 63.5-103.529870.71 25.00-25.50 51.5-91.529870.72 63.5-103.5

32


7.1.3 Package supports for ampoules (Ø 25.5 to 29 mm)


Package support

model N°

00 4

0091

7-R

00 4

0091

6-R

00 4

0082

6-R

00 4

0091

500

400

914-

R00

400

913-

R00

400

912-

R

Ø D

(ran

ge)

l(ran

ge)

Ø d

(max

)

L(m

ax)

29870.73 25.50-26.00 71.5-91.529870.74 83.5-103.529870.75 26.00-26.50 71.5-91.529870.76 83.5-103.529870.77 26.50-27.00 71.0-91.029870.78 83.0-103.029870.79 27.00-27.50 71.0-91.0 15.90 145.029870.80 83.0-103.029870.81 27.50-28.00 70.5-90.529870.82 82.5-102.529870.83 28.00-28.50 70.5-90.529870.84 82.5-102.529870.85 28.50-29.00 70.5-90.529870.86 82.5-102.5

33


7.2 Package supports for vialsThe tables on the following page enables you to select the appropriate ORBISPHERE package support based upon your vial size. If you cannot match your vial size with one of the available supports listed in these tables, then a customized package support will be required.

Determine the following four dimensions of your vial and then use the accompanying tables to find out which package support you need.

Dimension restrictions (for second and third groups of the table):

• d -The cap diameter must be smaller than 28 mm.

• n -The vial diameter at 13 mm below the cap must be smaller than 30 mm.

Note: References to D and L in the tables, refer to the diagram illustrated above left.

Package Support Required:

D= mm Use this value to identify the correct package support group in the table. Select the group corresponding to your measured vial diameter. This value must fall within the range given by the table for the group.

L = mm Check first that this length is smaller than the maximum length acceptable for the package support group identified. Then round up L to the nearest mm, and use this value as the last digits of the package support model number (in place of the .XX or .XXX in the table).

Model 29871.__ __.__ __ __ This is the package support model number to order, based upon the above parameters and the table on the next page.

34


7.2.1 Package supports for vials (Ø 12 to 57 mm)Note: XX and XXX in the tables is always a multiple of 5 millimeters. So for package support 29871.14.XX where a length of 38 millimeters is required order part number 29871.14.40, and if 53 millimeters is required order part number 29871.14.55).

Vial Dimensions in mm



Package Support Model N°

Ø D(range) L(max)


Ø D(range) L(max)


Ø D(range) L(max)

29871.01.XX 12.00–12.50

72.00

29871.31.XXX 27.00–27.50

105.00

29871.61.XXX 42.00–42.50

138

29871.02.XX 12.50–13.00 29871.32.XXX 27.50–28.00 29871.62.XXX 42.50–43.0029871.03.XX 13.00–13.50 29871.33.XXX 28.00–28.50 29871.63.XXX 43.00–43.5029871.04.XX 13.50–14.00 29871.34.XXX 28.50–29.00 29871.64.XXX 43.50–44.0029871.05.XX 14.00–14.50 29871.35.XXX 29.00–29.50 29871.65.XXX 44.00–44.5029871.06.XX 14.50–15.00 29871.36.XXX 29.50–30.00 29871.66.XXX 44.50–45.0029871.07.XX 15.00–15.50 29871.37.XXX 30.00–30.50 29871.67.XXX 45.00–45.5029871.08.XX 15.50–16.00 29871.38.XXX 30.50–31.00 29871.68.XXX 45.50–46.0029871.09.XX 16.00–16.50 29871.39.XXX 31.00–31.50 29871.69.XXX 46.00–46.5029871.10.XX 16.50–17.00 29871.40.XXX 31.50–32.00 29871.70.XXX 46.50–47.0029871.11.XX 17.00–17.50 29871.41.XXX 32.00–32.50 29871.71.XXX 47.00–47.5029871.12.XX 17.50–18.00 29871.42.XXX 32.50–33.00 29871.72.XXX 47.50–48.0029871.13.XX 18.00–18.50 29871.43.XXX 33.00–33.50 29871.73.XXX 48.00–48.5029871.14.XX 18.50–19.00 29871.44.XXX 33.50–34.00 29871.74.XXX 48.50–49.0029871.15.XX 19.00–19.50 29871.45.XXX 34.00–34.50 29871.75.XXX 49.00–49.5029871.16.XX 19.50–20.00 29871.46.XXX 34.50–35.00 29871.76.XXX 49.50–50.0029871.17.XX 20.00–20.50 29871.47.XXX 35.00–35.50 29871.77.XXX 50.00–50.5029871.18.XX 20.50–21.00 29871.48.XXX 35.50–36.00 29871.78.XXX 50.50–51.0029871.19.XX 21.00–21.50 29871.49.XXX 36.00–36.50 29871.79.XXX 51.00–51.5029871.20.XX 21.50–22.00 29871.50.XXX 36.50–37.00 29871.80.XXX 51.50–52.0029871.21.XX 22.00–22.50 29871.51.XXX 37.00–37.50 29871.81.XXX 52.00–52.5029871.22.XX 22.50–23.00 29871.52.XXX 37.50–38.00 29871.82.XXX 52.50–53.0029871.23.XX 23.00–23.50 29871.53.XXX 38.00–38.50 29871.83.XXX 53.00–53.5029871.24.XX 23.50–24.00 29871.54.XXX 38.50–39.00 29871.84.XXX 53.50–54.0029871.25.XX 24.00–24.50 29871.55.XXX 39.00–39.50 29871.85.XXX 54.00–54.5029871.26.XX 24.50–25.00 29871.56.XXX 39.50–40.00 29871.86.XXX 54.50–55.0029871.27.XX 25.00–25.50 29871.57.XXX 40.00–40.50 29871.87.XXX 55.00–55.5029871.28.XX 25.50–26.00 29871.58.XXX 40.50–41.00 29871.88.XXX 55.50–56.0029871.29.XX 26.00–26.50 29871.59.XXX 41.00–41.50 29871.89.XXX 56.00–56.5029871.30.XX 26.50–27.00 29871.60.XXX 41.50–42.00 29871.90.XXX 56.50–57.00

Dimension restrictions:• d -The cap diameter must be smaller than 28 mm.• n -The vial diameter at 13 mm below the cap must be smaller than 30 mm.

35

Section 8 Glossary of Terms

8.1 Common units

8.2 Terms and definitions

Table 2 Common units

Unit Meaning

% percentage, by weight

% vbar percentage per volume, barometric pressure referenced

% vext percentage per volume, sample pressure compensated

cc/kg cubic centimeters per kilogram

g/kg grams per kilogram

mg/L milligrams per liter

mL/L milliliters per liter

ppb parts per billion, by weight

ppm parts per million, by weight

v/v volume per volume (ratio)

Table 3 Terms and definitions

Terms Meaning

Absolute pressure Absolute pressure is relative pressure, plus atmospheric pressure

Concentration The relative content of a component in a gaseous or liquid media.

Conductivity The reciprocal of electrical resistivity.

Headspace The empty volume above a liquid or solid in a closed container.

Relative pressure Relative pressure is absolute pressure, less atmospheric pressure (this is the customary gauge reading).

Resistivity The opposition offered by a body or substance to the passage through it of a steady electric current.

36

Glossary of Terms

orbisphere model 29981 - hach india

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