baju steril austar pharmaceutical & medical consumables-20140324

PHARMACEUTICAL &

MEDICAL CONSUMABLES

Cleanroom contamination control products & Sterility assurance 5.

Cleanroom Stainless Steel Products 4.

Laboratory Equipment 3.

Cleanroom Products 2.

ATMI Ultraclean Sterile Packaging 1.

Index

ATMI-AUSTAR

ATMI life science and Austar Ltd. established a joint venture ATMI-Austar packaging Technology (Beijing) Co.,Ltd as a advanced production technology, production management and equipment are all provided by ATMI Life science.

Factory facilities conform to EU standards with ISO 5 production environment, perfect quality system, high -quality staff, and customer change notification system to provide guarantee for high quality and uniform products.

Ultraclean PE bags/Film

Tyvek & HDPE bags/Roll

Ultraclean Sterile LDPE Freeze-Dry Film

Powder Transfer Vessel/Clean Steam Transfer Vessel

IntergrityTM 2-D Bioprocess Vessel

IntergrityTM 3-D Bioprocess Vessel

ATMI-AUSTAR Product list

Application:

For packaging and /or gamma sterilization of :

stoppers, caps and closures

API,Medical powders

Vials and containers

buffers, media

Filters

Medical devices

Cleanroom garments

Syringe components

Organs

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Ultraclean PE bags

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Ultraclean PE bags

Highlights & Benefits

Low visible and subvisible contaminants level

Low bioburden and endotoxin level

Low leachables and extractables level

Certified cleanliness level

Improved process efficiency

Pre-sterilized bags available upon request

(gamma irradiated at 25 kGy, certified)

Flexibility towards customized products

LDPE film is compliant to: FDA Title 21 Code of Federal Regulation 177.1520 Olefin polymers EU Directive 2002/72/EC relating to plastic materials and articles intended to

come into contact with foodstuffs and its amendments

USP , biological reactivity test in vivo, class VI

USP , biological reactivity test in vitro

USP , physicochemical test plastics

EP monograph 3.1.3, Polyolefins

EP monograph 3.1.4, Polyethylene without additives for containers

for parenteral and ophthalmic preparation

EP monograph 3.2.2, plastic containers and closures for pharmaceutical use

LDPE film is Animal Derived Component Free (ADCF)

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Ultraclean PE bags

Order Information:

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Ultraclean PE bags

specification size(WLT)m packaging

PEF-BS-550750100 5507500.1 50pcs/double bag;300pcs/carton

PEF-BS-10001200100 100012000.1 30pcs/double bag;180pcs/carton

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Application

For Steam, EO, Gamma irradiation Sterilization of :

stoppers, caps and closures

vials and containers

syringe components

stainless steel lab or process equipment

Medical devices

Cleanroom garments

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Benifits

Ultra pure & clean bag with low particle, bioburden & endotoxin level (certified cleanliness level)

Sterilization indicator switching color when exposed to Steam

Strong bag with high resistance to tear and puncture

Outstanding resistance to microbial penetration

High sterility integrity until package is opened

Increased process efficiency

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Highlights & Features Vertically integrated production process with in-house extrusion of the

HDPE from certified virgin resins without the use additives in ultra clean environment

In-house cleaning of uncoated Tyvek 1073B

Production in ISO class 5 cleaning rooms

cGMP certified and focussed company, exclusively servicing the life sciences industry

Easy-Tear option for better opening and sealing

Standard items available from stock

Flexibility towards customized products

Change notification policy in place

Dye-penetration test (methylene blue) to show packaging integrity

Specification

Cleansteam Bags

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Ultraclean PE bags

specification Size(WL)mm Packaging

TY8E16P0000-0001 200x300 100pcs/double

bags 10bags/carton 1000pcs/carcon

TY8E16P0000-0002 320x450 100pcs/double


TY8E16P0000-0003 400x500 100pcs/double


TY8E16P0000-0004 500x650 100pcs/double


TY8E16P0000-0005 1200x120 25pcs/double


TY8E16P1148-0001 900x900 25pcs/double


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Benifits Low visible and subvisible contaminants level Low bioburden and endotoxin level Low leachables and extractables level Certified cleanliness level High product recovery Improved process efficiency Flexibility towards customized products Save energy, labor cost and, production time, energy cost. Pre-sterilized bags available upon request (gamma irradiated at 25 kGy,

certified)

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Specification:

Size(WLT)mm packaging

UP1-BS-9501060100 95010600.1 30pcs/double bag; 10bags/carton

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Powder Transfer Vessel

/Clean Steam Transfer Vessel

Applications

Integrity PTVs Powder Transfer Vessels are widely utilized in the biotechnology and classical pharmaceutical industries at all process

scales, from research to high-volume manufacturing. Applications

include contained transfer, storage or shipping of:

Dry powder media Filter aids Buffer salts Excipients

Rubber Stoppers Flip caps

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Powder Transfer Vessel

/Clean Steam Transfer Vessel

Key Benefits Flexible bag design is easy to manipulate and offers good ergonomics Anti-static dissapative materials reduce powder loss and explosion risk Tri-clamp connectors give broad compatibility and superior process seal to

stainless steel or single-use receptacles

High product recovery (typically >99.95%) Superior containment improves process integrity and prevents powder from

escaping into the workspace

Vessel contents are clearly visible Eliminates the need for cleaning and validation, and the associated waste and

delay

Compatible with high-containment split butterfly valve technology( valve) and other third-party containment devices

Small size for ease of storage

Efficient movement and storage of liquids is critical to modern biotechnology processes.

The deployment of single-use containers for

this task has become ubiquitous in recent

years because they reduce risk while also

driving down costs in comparison with

traditional stainless steel equipment.

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Intergrity 2-D Bioprocess Vessel

At the heart of ATMIs Integrity systems and products is Integrity TK8 film, a state-of-theart

multi-layer gas-barrier polymer laminate. The

product-contacting layer of TK8 film is blow

extruded in-house by ATMI under cleanroom

conditions using medical-grade ultralow-density

polyethylene resin, then laminated to create a

gas barrier film of exceptional cleanliness,

strength and clarity that is animal derived

component free (ADCF) and complies fully with

USP Class VI requirements.

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Highlights

State-of-the-art designs and materials

Manufactured on automated equipment under ISO

Class 5 (class 100) cleanroom conditions

Suitable for any storage application virtually

Standard and custom configurations available

Integrity tested using ATMIs advanced whole-bag

testing technology

Universal TK8 bioprocess film

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ATMIs Integrity 3-D Bioprocess Vessel (BPV) products have been developed to meet the demand for cost-effective, scalable single-use liquid storage containers that are compatible with ATMIs market-leading range of single-use mixing and bioreactor technologies.

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At the heart of ATMIs Integrity systems and products is Integrity TK8 film, a state-of-theart multi-layer gas-barrier polymer laminate. The product-contacting layer of TK8 film is blow extruded in-house by ATMI under cleanroom conditions using medical-grade ultralow-density polyethylene resin, then laminated to create a gas barrier film of exceptional cleanliness, strength and clarity that is animal derived component free (ADCF) and complies fully with USP Class VI requirements.

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Highlights

State-of-the-art designs and materials

Manufactured on automated equipment under ISO Class 5 (class 100) cleanroom conditions

Suitable for any storage application virtually

Standard and custom configurations available

Integrity tested using ATMIs advanced whole-bag testing technology.

Universal TK8 bioprocess film

Wipers: Microfiber wiper: MicroPolx 2750 Wide sealing microfiber wiper

Sealed-edge microfiber wiper

Polyeaster wiper: LTK3000I, LTK3000E and LTK 2020

Non-woven wiper

Cleanroom paper Cleanroom swabs Cleanroom access mats Mopping system Cleanroom mop Cleanroom gloves Cleanroom clothes/underwear/Boots Shoes cover machine

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Cleanroom Product list

Recommended for using in ISO Class 4-5 (Class 10-100) Cleanroom.

Works well with IPA and other solvents

Excellent absorption with de-ionize water and oils.

Smooth texture is ideal for cleaning delicate part, pre-cleaning, degreasing,

polishing & buffing

paintwork, plates & lenses

Its physical attributes make it ideal for using in critical manufacturing

environments of the following applications:

TFT-LCD

Hard Disk Drives

Semiconductors

Pharmaceutical

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MicroPolx 2750

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MicroPolx 2750

ORDER INFORMATION:

Product Item Number Size/Metric Shts/Pk Pks/Cs

MicroPolx 2750 MPX275.0909.10 9x9/23x23cm 100(stack) 10

Material: Polyester and nylon blended micro denier continuous filament yarn Cutting method: Sealed cut Basic weight ( g/ m2 ) 175 5 Size ( Inc. ): 12 12 ( 5) ; 9 9 ( 5) Absorbency : Sorptive capacity ( ml/m2 ) : 330 ; Sorptive rate ( Sec ) : 3

ION ( ppm ): Sodium ( Na+ ) 0.5 ; Potassium ( K+ ) 0.5 ; Calcium ( Ca2+ ) 0.5 ; Chloride ( Cl- ) 0.5 NVR ( ppm ) : IPA extract 500 ; DIW extract 500 LPC ( counts/ m2 ) 0.5um 10 106 Dry flex test 0.3um ( counts/ft3 ) 9 9 300 ; 12 12 500 Package 12 12 100 Pcs/Bag 10 Bags/Ctn. 9 9 100 Pcs/Bag 10 Bags/Ctn.

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LTK3000I

Material: Polyester and nylon blended micro denier continuous filament yarn Cutting method: Sealed cut Basic weight ( g/ m2 ) : 225 10 Size ( Inc. ): 12 12 ( 5) ; 9 9 ( 5) absorbency: Sorptive capacity ( ml/m2 ) : 350 ; Sorptive rate ( Sec ): 3 ION ( ppm ) Sodium ( Na+ ): 0.5 Potassium ( K+ ) 0.5 Calcium ( Ca2+ ) 0.5 Chloride ( Cl- ) 0.5 NVR ( ppm ) : IPA extract : 500 ; DIW extract : 500 LPC ( counts/ m2 ) 0.5um 10 106 Dry flex test 0.3um ( counts/ft3 ) 12 12 500 9 9 300

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LTK3000E

100% polyester continuous filament yarn. Excellent tearing strength. Highly absorbent. Standard weight. Extremely low ion content, particle generation and extractable residue. All four edges are 4mm ultrasonic sealed borders. Compatible for Class 1, 10 or 100 cleanroom.

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LTK 2020

Item: Advanced & Economic

Size: 9"x9"/12"x12"

Packaging: 100pcs/bag,30bags/ctn;150pcs/bag,40bags/ctn

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Non-woven wiper

Various colours include white, blue, green, yellow and pink Various sizes include A3, A4, A5, Letter and etc. Custom colours and sizes are also available Double packed for cleanliness Smooth surfaces reduce particle contamination Cellulose sourced from sustainable managed forests Complies with RoHS 2002/05 and REACH requirements Lot traceability on each case High strength and heat resistance Good toner adhesion 100% recyclable

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Cleanroom Paper

Sampling swab

Cleaning swab

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Cleanroom Swab

Material: PE film coated with adhesive

Size: 18"*36/18"*45/24"*36/26"*45 36"*36/36"*45

Color: Blue/White

Packaging: 30sheets/pad,10pads/box,5 boxes/carton

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Cleanroom access mats

Material: stainless steel mop rod and ESD microfiber head.

The feature: The head can be rotated 360, sterilized at 121, and absorb

vapor and powder effectively.

Mop head size45x17cm/60X17cm

Mop rod: 1.3m

Packaging: 1pc/vacuum packing

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Cleanroom Mop

Feature: Powder-free, comply with FDA requirement; polymer coating design;

processed by DI water; Gamma irradiation.

Length: 300mm

Size: 6.0~8.5

Packaging: 1 pair/ wallet/ Paper bag, 50 pairs/Box, 6 catton/case.

Standard: YZB/HU2411-66-2011

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Sterile power free Latex Gloves

Material: 100% pure Nitrile without plasticizers. Contain no

Phthalate Esters, Silicone oil and Amide.

Length: 300mm (12")

Size: S/M/L

Surface: fingertip textured

ISO class 5/ISO class 6

Feature: laundered with 0.2micron filtered high resistivity

D.I. water and packed in certified cleanroom

enviroment.

Packing: 500pairs/carton

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Non- Sterile Latex Gloves

Material: 100% pure Natural Latex without plasticizers. Contain

no Phthalate Esters, Silicone oil and Amide.

Length: 300mm (12")

Size: S/M/L

Surface: Fingertip textured

ISO class 5/ISO class 6

Feature: laundered with 0.2micron filtered high resistivity

D.I. water and packed in certified cleanroom

enviroment.

Packing: 500pairs/carton

Packing: 20*10 (200 pairs)

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Non- Sterile Latex Gloves

The fabric Material: Polyester filament fiber & conductive fiber Size: S-5L

Color: Multicolor

Feature: The clothes can be sterilized at 121 . The fabric can absorb sweat well and prevent bacterium,

tiny dust and liquid effectively, and keep clean.

It still can maintain excellent performace after 100-time cleaning

and disinfection.Sizes and style can be customer-tailored.

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100-time cleaning and sterilizing cleanroom clothes

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Technical Data of Cleanroom clothes

The fabric Material: Polyester filament fiber & conductive fiber Size: S-3XL

Color: Multicolor

Feature: The clothes can be sterilized at 121 . The fabrics can absorb sweat well and prevent bacterium,

tiny dust, and liquid effectively, and keep clean.

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Cleanroom clothes

The fabric Material: Nylon filament fiber + conductive fiber Size: S-3XL

Color: White

Feature: The underwear can be sterilized at 121 . The fabrics can absorb sweat well and prevent bacterium,

tiny dust, and liquid effectively, and keep clean.

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Cleanroom underwear

Materials: the ESD fabrics and rubber.

Size: 23-26

Feature: The boots can be sterilized at 121 .

The bottom is anti-slip and anti-stab, and protect the feet from injury in workshop.

The customer can choose advanced or economic types.

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Cleanroom boots

Product: QY-I100

The feature: The UV light disinfection Automatic show counting 2s-3s loading

shoe cover

The application: Cleanroom, laboratory, medical place

The capacity: PE 100pcs shoe cover

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Shoes cover machine

Vertical Autoclave

Laboratory Equipment

Biochemical /Mildew

Incubator

CO2 Incubator Sealing machine

Biosafety Cabinet Drying Oven Horizontal Shaker

Incubator

Microbiological air

sampler

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Cleanroom other products

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Cleanroom Stainless Steel products

Quaternary disinfectant

Phenolic disinfectant

Isopropyl alcohol disinfectant

Hands sanitizer

Rustbuster of stainless steel surface

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Cleanroom contamination control & Sterility

assurance products

baju steril austar pharmaceutical & medical consumables-20140324

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