Sterile Packaging: Validation Powered By PM’s
To ensure sterile packaging, quality and performance of the machinery are vital. Medical device makers, as well as pharmaceutical companies, require packaging machinery that has the mechanisms that can create a seal that conforms to the serious nature of sterile packaging. However, this equipment is only as good as the process set-points that were developed during the validation of the equipment, and just as important the way in which the machinery is maintained. As we said in the 90’s “Garbage in Garbage out” in short your equipment will only create a quality seal based on the type and condition of the equipment that created the seal.
Critical machinery must be regularly inspected to ensure all key systems and components are operating correctly. A strong preventive maintenance plan will:
- Decrease chances of equipment downtime
- Increase the life of the equipment
- Maintain optimal equipment efficiency
- Increase the safety of the equipment
- Increase system reliability
- Increase production levels
- Reduce the risk of future recalls
Sterile Packaging Standards
The Good Manufacturing Practice (GMP) documentation of the Food and Drug Administration requires some specific standards in medical device packaging maintenance. Device manufacturers must clean, maintain and adjust equipment, where failure to do so could have an adverse effect on the equipment’s operation. For example, failure to maintain, clean and adjust a sealing and/or packaging machine used for packaging of sterile devices will eventually result in defective packages, and thus, non-sterile products.
A manufacturer must determine if the equipment requires maintenance and apply the appropriate parts of the GMP requirements for the equipment. If it is necessary to maintain, clean or adjust equipment, the manufacturer must:
- Have a written schedule for performing these activities
- Post the schedule or make it readily available
- Document the activities
- Where adjustment is necessary to maintain proper operation, post the inherent limitations and allowable tolerances of the equipment or make these available to personnel
- Audit the activities and document the audit
When to Schedule a Preventive Maintenance Program
The right time will vary for different equipment and the nature of the work; some machines need very consistent maintenance schedules, while others may function fine with more occasional servicing. The interval between programs and usage will determine the scheduling of maintenance programs. Moreover, there is a phase when every machine will begin showing preliminary signs of wear and tear. Avoid allowing this period to progress by scheduling a program early. Parts assembly and calibration should be completed by professionals who have a strong understanding of the equipment. Also, high temperatures, setting over 300f, will create shorter PM cycles, other factors may play upon PM cycles such as unique workflow behavior as well as environment specific to your operation. So no real panacea exists for writing your PM program, by all means, query manufacturing recommendations but avoid the temptation to copy and paste these boilerplates into a policy. Pouch testing is vital to help guide your living PM plan for medical packaging equipment. I have always said a pouch tester is the best guide to service cycles. Also vital is to keep the most common replacement parts, such as consumable parts like heating elements, silicone rubber, and glass tape on hand. This is manufacturing 101, I know, but it is surprising to see how many of our customers have stopped their entire operation over a $20 part. These parts are very specific to your equipment and you will not find them at the local hardware store. Keep these parts in stock and keep shipping your products.
As appropriate, maintenance records should be maintained for each piece of equipment. There is no GMP requirement that I know of for written maintenance procedures, although one is recommended to assure that all aspects of maintenance are covered.
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The message is clear from 3rd party regulator agencies, any machinery that is tied to sterile devices MUST be carefully monitored and maintained.