FDA impact on cleanroom equipment design
09/01/2002
The FDA is changing the way pharmaceutical companies are conducting their clean operations. Stop here if you've heard this one before.
by Hank Rahe
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Recently, several large-scale aseptic operations have been cited with a "483" for transporting vials from an ISO Class 5 filling area, through a non-controlled area, to the freeze drier, but failing to maintain an ISO Class 5 environment for the partially closed vials during the entire transport.
Typically, the vials are loaded onto trays, the trays are then loaded into the ISO Class 5 environment of a closed cart and then wheeled through a common hallway to an adjacent area. In this process, the cart acts as a static carrier, having no controlled environment other than what it picked up in the filling area. The FDA asked these companies in question to show that the conditions in the cart met ISO Class 5 conditions. They were unable to do it.
To solve this problem, new carts are being developed to provide onboard filtration by utilizing battery-powered HEPA filter units that create a positive-pressure ISO Class 5 environment. However, the cart design is not as easy as it would seem and the answer is not to simply blow HEPA-filtered air into the cart.
Consideration must also be given to the particles generated by movement, battery life and flow patterns of the air inside the cart. Neglecting these factors has resulted in several failed attempts-by contamination control companies who do not understand the dynamics of the transport of vials-to build such a cart.
Several hundred vials are fitted into a tray in normal circumstances. The slightest movement of the transport cart and the vials can cause them to rub against one another and generate thousands of particles. As mentioned, another challenge is the design of the airflow patterns, as well as the correct velocity to use to maintain the ISO Class 5 during the journey across less than "perfectly smooth" floors.
The cart design itself is also critical, because what was a smaller, lighter unit has grown in both weight and size. The cart must also accommodate the HEPA filter and blower unit, as well as the battery power unit, while attempting to fit into existing areas where the smaller unit was used in the past.
Several traditional contamination control suppliers have failed in their attempts to build such a unit. Their designs do not address the dynamics of the operation, because most suppliers don't understand the process that they are asked to control. Those that do understand the process do not understand the tools available for contamination control.
The challenge for all is to bring about a better understanding through more complete communication. Formal communication, writing down and discussing the meaning of the words, is one effective means of closing the communication gap. Closing the gap also involves the skill of listening and then regurgitating what you thought you heard. One-way communication is a disaster when each party holds a critical piece to solving the on-going contamination control puzzle.
Hank Rahe is director of technology for Containment Technologies Group and is a member of the CleanRooms Editorial Advisory Board.
Book 'em, Danno
A "483" is like a speeding ticket. If the FDA finds something that is not compliant, it issues the 483 to the company pointing out the deficiency. The company must respond and provide corrective action to fix the problem.