Case Study: Clean Rooms For International Pharmaceutical Company Penmann were contracted to design, supply and install the plant to serve a new Pharmaceutical Aseptic Filling Suite. The Suite comprised a Grade C (Class 10,000) environment for preparation rooms, air locks and change areas, and a Grade B (Class 1,000 operating) environment for the assembly area with a localized Grade A (Class 100) area within assembly area.

The Suite was designed with a cascading air pressure design ranging from 45Pa in the assembly area down to 0Pa in the dirty corridor. The pressure balance had to be maintained with a variety of equipment operating conditions which affected exhaust volumes from the area and leakage rates through machinery straddling boundaries.

There was also a requirement to allow the assembly area to drop to a set back pressure, lower than adjacent areas, during maintenance modes.

HEPA filtration was provided to H14 classification utilizing factory assembled disposable ceiling terminals.

Constant air volumes were maintained by a combination of frequency inverters control of the fans and in duct constant volume devices to compensate as filters start to block and reduce air flow

A 9m˛ Grade A environment was provided adjacent to the autoclave serving the assembly area utilizing a laminar flow canopy and polycarbonate partition.

The plant was fully commissioned and validated on completion, including provision of all necessary qualification documentation.

Key Features

• Pressure cascade
• Secondary pressure option for maintenance mode
• Self regulating pressure stabilizers
• Pressure maintained over high range of machinery exhaust volumes