belco packaging systems - tray sealing on shuttle style heat sealers
DESCRIPTION
Presentation made to MD&M MN Conference in 2006 by Tom Misik, VP Sales Belco Packaging Systems, Inc. Equipment Considerations For Thermoformed Tray Sealing On Shuttle Style Heat SealersTRANSCRIPT
MD&M MN 2006 Conference
Packaging Engineering-
Equipment Considerations for Thermoformed Tray Sealing on Shuttle Style Heat Sealers
Section 1.What to consider in order to
Seal product in Trays
Intended Use
ISO 11607
Validation
Profitability
Why Seal Trays?Consider Intended Use
4.1.3.1- The intention of packaging for terminally sterilized medical devices is to maintain the sterility of the product with respect to it’s intended use, shelf life, transport and storage conditions.
Why Seal Trays?Consider Intended Use
Typically, you take an assembled device placed in your thermoform/tray, place one tray into each of the fixture cavities. Each cavity must be occupied during every sealing cycle. Then place the die-cut lid material on top of every tray. The entire tray seal flange must be covered by the lid material, in a consistent manner.
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Why Seal Trays?Consider Intended Use
General practices call for flange thickness to be consistent +/-0.006” around the overall perimeter of the tray, with the lid material being at least 0.015” beyond any seal flange.
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Why Seal Trays?Consider Intended Use
The seal fixture now contains your complete device. It is then indexed into the tray sealer chamber, where your validated process parameters of time, temperature, and pressure are automatically applied.
Why Seal Trays?Consider Intended Use
When finished cycling, the seal fixture is retracted from the chamber, the sealed packages are removed from the tray cavities.
Why Seal Trays?ISO 11607
Consider Process ControlTime
Dwell time plus contact pressure timeContact pressure time only
Why Seal Trays?ISO 11607
Consider Process ControlTemperature
Controller accuracyThermocouple accuracyDistribution at the platen surface
Why Seal Trays?ISO 11607
Consider Process Control Pressure (Air)
– Incoming House Air & Connection Fittings
Supply Air Line Size Air Quality
– Contact Pressure Square inches of seal area Cylinder size
Why Seal Trays? Consider Validation
Validation Defined as-“Establishing documented evidence which
provides a high degree of assurance that a specific process will consistently produce product meeting its predetermined specifications and quality attributes”
FDA Process Development Guide
Why Seal Trays? Consider Validation
Installation Qualification– Has your supplier satisfied your
acceptance criteria? – Have you complied with the machinery
manufacturers written instructions?– Has the equipment been calibrated?
Why Seal Trays?Consider Validation
• Operational Qualification• Ability to monitor process parameters
• Process alarms
• Documents and manuals• Perform a challenge to the verified
consistent operation of the machine• Prior to making your first package
Why Seal Trays?Consider Validation
Process Qualification– Forming and Sealing are considered to be
the “Most Critical” processes– Challenging of the process variables to
determine your process windowSeal Closure IntegritySeal Strength
Why Seal Trays? Consider Profitability
After consideration is given to the material discussed so far, you still need to seal product.
Two seal stations provide for flexibility, while a single shuttles economize clean-room floor space.
A two-station shuttle machine addresses productivity quantities defined here…
Packages per Minute
Packages per 50 min Hour
Packages per 8 hour
Day
Packages per 40 hour Week
Packages per Month ( 21.6 Days )
Packages per Year 260 work days
1 50 400 2,000 8,640 104,000
2 100 800 4,000 17,280 208,000
3 150 1,200 6,000 25,920 312,000
4 200 1,600 8,000 34,560 416,000
5 250 2,000 10,000 43,250 520,000
6 300 2,400 12,000 51,880 624,000
7 350 2,800 14,000 60,530 728,000
8 400 3,200 16,000 69,180 832,000
9 450 3,600 18,000 77,830 936,000
10 500 4,000 20,000 86,500 1,040,000
11 550 4,400 22,000 95,138 1,144,000
12 600 4,800 24,000 103,789 1,248,000
13 650 5,200 26,000 112,440 1,352,000
14 700 5,600 28,000 121,091 1,456,000
15 750 6,000 30,000 129,750 1,560,000
16 800 6,400 32,000 138,395 1,664,000
17 850 6,800 34,000 147,047 1,768,000
18 900 7,200 36,000 155,698 1,872,000
19 950 7,600 38,000 164,349 1,976,000
20 1,000 8,000 40,000 173,000 2,080,000
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PRODUCTIVITY RATE CHART
Section 2. - What to look for in a Tray Sealer Manufacturer Complementary Vendor Knowledge
– Thermoforming Companies– Lid Material Converters– Brokers / Distributors– And these vendors know the machine
manufacturer Ability to recognize items of concern with
these materials– Work together with the material suppliers to bring
the finished package together
What to look for in a Tray Sealer Manufacturer
Seal Fixture Program– Warranty of finished product quality– Guarantee to meet delivery timeline– Discovery of initial process parameters– Engineering documents to allow 1st article
inspectionsNo Surprises
What to look for in a Tray Sealer Manufacturer
Maintenance Support– FAT Program (Factory Acceptance Test)
Demonstrate compliance with your criteria
– PM Program (Preventative Maintenance)At least a written procedure for self sufficiency
– Start Up Supervision Program In lieu of a FAT visit
What to look for in a Tray Sealer Manufacturer
PMMI Membership– www.pmmi.org– www.packexpo.com
• www.devicelink.com• Word of Mouth Reputation
– From your colleagues– From your Thermoformer– From your Lid Supplier
Summary
Understand the steps involved with the packaging process– Allow enough lead time
Expect delivery of a turn-key system heat sealing system
Expect the various vendors selected to-– Work with each other– Assist and offer guidance based upon practical
experiences
Where to Get More Information
ISO 11607-– Association for the Advancement of Medical
Instrumentation Validating Medical Packaging-
– Ron Pilchik / CRC Press Dupont Medical Packaging
– Technical Reference Guide for Medical Packaging www.devicelink.com
– Thermoformers, lid materials, machinery manufacturers, consultants
Questions and Answers
Contact Information:
Thomas MisikBelco Packaging Systems, Inc.
800.833.1833 X [email protected]
www.belcopackaging.comwww.belcomedical.com