Packaging Machine Validation

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Capabilities

• IQ
• OQ
• PQ
• Process analysis
• Help with URS compilation
• Design of experiments
• Validation of production and packs
• Clean room monitoring
• Packaging Machine Validation
• Testing Equipment Validation

Our packaging and automation equipment is supplied as a validated package, typically to GAMP4, 21 CFR part 11 is also available on bespoke systems, as is six sigma analysis.

The packaging of a medical device has several critical functions. This service examines whether the packing process delivers adequate seals to ensure product environment maintenance over the claimed shelf life of the product. Similar principles apply whether the goal is to maintain sterility or a moisture barrier or some other specific atmosphere.

A validated production process is required as many of the quality assurance tests for packaging are destructive.

The approach is based on ISO "11607 Packaging for Terminally Sterilised Medical Devices", using the example of peel pouch sealing machine. The standard takes a holistic approach to pack manufacture but this service is restricted to machine operational considerations.

As with any validation process we need to start out with a plan. To make a plan we need to know what we should be looking for. The Failure Mode and Effect Analysis FMEA is a good place to look for what to test. We also need to define what a pass and fail result is.

Typical Plan

1. Brainstorm FMEA and Risk Analysis (RA)
2. Define parameters to test
3. Identify test methods
4. Define desired outcomes
5. Perform analysis.
   1. FAT
   2. IQ
   3. OQ
   4. PQ
6. Verify performance following post-production processes or shelf life.

Possible Test Methods

Seal strength

• Tensile strength test (ASTM F-88)
• Peel strength (90 degree tensile shear EN868)
• Burst strength (ASTM F1140)

Seal integrity

• Fibre transfer (during peel)
• Burst strength (gross leaks only)
• Dye penetration (EN 868-1 Appendix F/ ASTM F 1929)
• Vacuum decay non destructive leak test /li>

Appearance

• Visual inspection

The first phase of a validation study is carried out at the machine manufacturers. Here initial ranges can be identified for the variable elements of the process. This is often referred to as Factory Acceptance Trials (FAT). In ISO 11607 this process starts with Equipment Qualification. The checklist should include the following types of parameters:

Parameter	Measure
Web material and variability compatible with equipment.	Tested over range and documented.
Temperature, pressure and speed measurement devices available and calibrated if required.	Documented.
Upper and lower temperature operating range identified for each element.	Recorded
Upper and lower pressure range identified for each element.	Recorded
Upper and lower speed range identified within temperature and pressure ranges.	Operating window recorded.
Operation and set up manuals available.	Documented.
Maintenance and cleaning procedures and schedules available	Documented.
Software validated if bespoke	Documented.
Operator training delivered	Documented.
Overall machine design and assembly in compliance with cGMP principles.	Verified and documented.

Installation Qualification (IQ)

Once the equipment is delivered and is in its manufacturing environment the usual validation process is the Installation Qualification. The goal here is to show that machine is functioning correctly and that all documentation is in place. All measurement and alarm devices should be working correctly and all process elements perform as expected.

Product specific set up procedures can also be developed at this stage.

The standard also calls for visual inspection to verify that the product is correctly positioned in the pack. This inspection combined with any seal integrity testing will identify any damage (such as tears or punctures) caused to the web during packaging or other processing.

Process Performance Qualification (PQ)

Next is the key area in the machine validation: Process Performance Qualification. We go to multi batch runs at the window extremities to ensure that the equipment produces good quality packs when no alarms are sounding. It is normal to run each set of conditions on 3 separate batches and look for congruence of results.

Verification of performance post-production or shelf life

Validated pack samples may need to be further tested to demonstrate that they are not adversely affected by such things as the sterilisation process, transit and storage.

Other Considerations

Other important performance considerations for packages not addressed in this validation include:

• User acceptance
• Biocompatibility
• Physical product protection
• Web material performance

There are many variables in the packaging process, the design of the pack and of product handling following packaging. There are however relatively few tests for examining pack performance. As ever a good plan and logical approach covering the extremes of process variables and handling possibilities can lead to a relatively simple validation process.