Medical Engineering Technologies - Medical Device Packaging Machine Validation

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Computer assisted bone remodelling studies help prosthetic manufacturers target their product designs on particular clinical needs. Optimisation and remodelling analysis is available through MET combined with: clinical model development, FE analysis, bone density mapping, loading analysis and remodelling studies. All this leads to optimisation of geometric designs, surface features, porosity and all the details of the implant.

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Material Testing for Product Development

Material selection is a crucial element in the early stages of developing a new product. Confidence in the performance properties and storage stability is essential to allow a project to proceed efficiently. MET's environmental chambers are used by clients to provide accelerated ageing for materials which are then tested in our laboratory. We can compare properties for fresh product and aged product to provide the design inputs to move your projects forward.

tensile testing

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Blister Packing Cost Effectively

Efficiency can be hard to achieve when packing medical devices into blisters. When production rates are not high many manufacturers source pre-formed blister trays externally. Lead times can be long and minimum order quantities high. In addition detailed incoming inspection is required as trays can be distorted in transport and storage and hence become more difficult to seal.

When using the RAMAC combined tray former/sealer trays are produced on demand. This reduces the opportunity for distortion; the storage space required and inventory costs. Typically 5,000 flat sheets of rigid PETG for forming 100mm square trays might cost 250 Euro and be available within a few days. Quality goes up and costs go down, perfect.

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Stent and Vascular Device Testing

As part of our 'excellence in medical device testing' programme MET has published an article on Endovascular Device Testing. This article will be useful to development engineers, QA engineers and regulatory professionals. It is published in the May edition of European Medical Device Technology.

The article can be found here.

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Efficient Blister Tray Packing

MET's first priority for blister lid sealing is the seal quality. We specify only the most rigid and robust medical tray sealers. For situations requiring efficient production we are now supplying the RAMAC combined tray forming / lid sealing machine.

The RAMAC 525 work station provides an efficient platform for packing: components, orthopaedics, kits, instruments, catheters and much more. The forming tools are liquid cooled, with vacuum and air plug forming techniques. The sealing tools deliver top quality seals and the PLC retains a large number of programmes to give that extra flexibility.

No need to stock a wide range of blister trays. Forming tool changes on the RAMAC 525 are completed in just a couple of minutes.

Lid-stock and tray forming materials are available from MET also.

For more information, please use our contacts page to request a call back.

tray-forming-and-sealing-workstation

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News Archive 1
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Because it is not possible to test every pack, packaging process validation is part of the essential requirements for medical device production, particularly for terminally sterilised medical devices. MET can perform installation, operational and production qualifications to ensure that manufacture is robust. By combining packaging process validation with our pack validation studies we provide you with the supporting evidence for your sterility and stability claims.

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

Brainstorm FMEA and Risk Analysis (RA)
Define parameters to test
Identify test methods
Define desired outcomes
Perform analysis.
1. FAT
2. IQ
3. OQ
4. PQ
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.