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Schering-Plough Case Study

Kenilworth, New Jersey
1300 Square Feet Class 100 – 1,000

The client had a requirement to place a sterile suite of research and pilot production clean rooms in a small area of a new building. The architectural engineering firm suggested that a clean room specialist be engaged to provide a complete installation.

Harris provided a certified clean room suite of three production rooms connected by a sterile corridor with airlock entries. The project included a highly advanced digital control and monitoring system that documents the performance of the Harris installation.

The design of the suite incorporates many features that benefit the client economically and operationally:

Complete Operational Independence
Each of the four major rooms has a completely independent air-handling system. There is no possibility of cross-contamination, and no need to rely on central building utilities to maintain specified control levels.

System independence also makes it much easier to reliably maintain the four separate room pressures which prevent cross-contamination between production areas.

Programmable Room Conditions
Two Lyophilizers open into one of the three production rooms. The mechanical system for this class 100 room was built like that of an environmental simulation chamber, allowing the operators to program and maintain any humidity control condition between 18 and 50% RH at 68ºF.

This means that new compounds can be processed across a wide range of humidity control levels to find their optimum processing conditions. It also means the atmospheric moisture load on the Lyophilizer cryopumps is cut by 65% -- allowing much faster pumpdown – which increases production rates.

Beyond GMP’s to Excellence
Unlike competitorsthat specialize only in electronic-grade clean rooms, Harris designs systems that meet and surpass minimum GMP requirements.

Harris provided pyrogen-free steam humidification, full HEPA ceilings rather than point-source filtration, raised floors to insure complete laminar flow throughout the room and hood exhaust systems that simplify fumigation.

Harris also installed a desiccant dehumidifier to insure stable humidity control even during summer extremes of temperature and humidity.

Most importantly, the system functions as an integrated whole. The client did not need to e concerned about questions of responsibility, conflicts between subcontractors, or confusion between an architect and engineer. Harris guaranteed performance to specifications, and provided a complete parts and labor warranty.

Harris Provided a Certified, Turnkey Installation which included:

Design and Construction