By Hank Rahe
Validation is a way of life within the pharmaceutical industry. There is an absolute need to be assured that our facilities and processes are consistent and repeatable. The documentation of the facilities and processes can add value if a practical approach is used in determining what actually needs to be validated.
That sounds quite simple and to the point; however, the grim reality is that there are many stories of less-than-value-added validation. For example, I was recently engaged in a discussion on how to validate a door outside the process area in a general corridor. Hours were spent discussing the door and the protocols necessary to capture the critical parameters of the door.
After much detailed discourse, the door was successfully validated and placed on an annual revalidation schedule. This success story resulted in not only wasted time and money, but also a potential future regulatory violation. I sleep better at night knowing that the door leading to a storage area has been successfully validated.
On a more serious note, the compounding pharmacy is a place where value-added validation should be coming to the forefront of discussion. These pharmacies are asked to prepare parenteral products, starting from base ingredients that are not sterile. This is standard practice for pharmaceutical manufacturers that have validated both equipment and process; however, for a typical compounding pharmacy, it can be far from routine.
Individuals involved with a typical compounding pharmacy don't have the engineering support or equipment required to provide a high level of assurance so that they can consistently produce a product with adequate sterility assurance levels.
In many cases, the equipment used to compound products is not designed for commercial parenteral product preparation. In the majority of cases, this equipment has not been validated to assure that it is performing as intended.
This lack of validation of processes and equipment in compounding pharmacies has resulted in several patient deaths. Both lack of knowledge and improper equipment use can be blamed for the tragic deaths. The autoclave, which has been cited as the root cause, is an example.
The typical autoclave used for “sterilization” in the compounding pharmacy has a single temperature probe located at the discharge for the condensate from the product chamber. When this probe reaches the critical temperature of 121 degrees Centigrade, a timer begins the countdown for the 15-minute sterilization cycle.
Most compounding pharmacists don't understand that the autoclave must be mapped to determine where to measure the critical temperature of 121 degrees Centigrade at the “coldest” point in the chamber. More importantly, items to be sterilized must reach temperature and be maintained at that temperature for the correct period of time. The autoclave must be tested and validated by measurement of the actual temperature of the product or component to be sterilized, not the discharge port of the chamber.
The compounding pharmacy community provides a valuable service to healthcare; however, they must practice their profession in a responsible way by reaching out to understand the equipment and methods used to produce products, and assure that their processes and equipment deliver a repeatable process.
Some compounding pharmacy owners feel that there is an additional “burden” being placed on them. According to this group, the need for proper facilities and equipment that can be properly validated will drive the pharmacies away from offering this type of service.
Every activity has a barrier to entry, be it expertise or cost. The cost of a single life wasted by not having properly validated facilities and equipment is far too high to allow a compounding pharmacy to continue without incorporating proper validation.
Hank Rahe is director of technology for Containment Technologies Group and is a member of the CleanRooms Editorial Advisory Board. He can be contacted at [email protected].