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Regulatory updates: EUGPM Annex 1 & TGA PE-009-08

Supplier: Kenelec Scientific
04 May, 2010

The TGA has recently announced that from July 1st 2010 it will be enforcing the new EUGMP Annex 1 regulations the TGA document PE-009-08 is essentially the same as EUGMP .

To help you understand the new requirements we have developed a presentation on this topic which is available by contacting our Cleanroom Monitoring Specialist.

One problem to overcome with this update

EU GMP Annex 1 portion for the monitoring of Capping Machines came into effect 1st March 2010 in Europe and will come into effect 1st July 2010 in Australia. This requires that the capping activities for all sterile products, not just those freeze dried products, be maintained under a Grade A zone quality air envelope.

To that effect all crimp capping activities should be performed as a "clean" activity, only if the crimp capping is performed within the aseptic core does the process need to be maintained as a sterile activity. All transfers from the aseptic core to the crimp capping machine must be done under unidirectional air flow meeting Grade A with the crimp capping machine located in a Grade C maximum room.

Are ISO class 5 (class A) conditions being maintained during the transfer of vials from the filling line to the freeze dryer?

Recently during one FDA inspection, a seemingly simple question brought on a major modification for many parenteral manufacturing operations.

What had been the industry norm and practice for many years was suddenly being challenged and most companies did not have the data to answer the off handed question.

Testing was quickly conducted to prove that such a question did not have merit. Surprising to many industry experts, the results showed that ISO class 5 (class A) conditions were not being maintained in the environment where partially stoppered vials were transported.

Panic arose on two fronts. The first concern was product integrity and second was finding a solution to the problem. The level of concern was somewhat mitigated by the fact that manufacturers felt that the problem would be relatively simple to correct. However, the design of a new cart has not been a simple task.

Many design attempts fail because of the many constraints and variables. A successful design requires unique engineering skills and an understanding of the facility and process. The answer was to build a cleanroom on wheels and to incorporate the advantages of an isolator by making the environment gas tight.

This solution required complex engineering and an understanding of the human interaction demanded by the process. Several companies attempted to make a cart that would offer a solution, but failed because of a lack of understanding of process interactions.

But one company has succeeded. Schaefer Technologies, based in Indianapolis has delivered the solution coupled with environmental monitoring from Kenelec Scientific. The technical details that had to be considered included were the understanding of the proper airflow velocities, pressurisation and patterns to deliver product protection within the carts and the limitations created by the physical facilities.

Because the facilities were designed to be as small as possible, the space in the filling line, loading areas and the freeze dryer, ISO class 5 (class A) zones are very limited. These space constraints played a major role in the functional requirements of the new cart design.

Time constraints also played a large role because of regulatory demands to get the problem fixed. This meant development of an acceptable solution had to be done quickly.