www.PDHcenter.com PDH Course M143 www.PDHonline.

org

- Washing of containers

b) US FDA requirements

• Critical area: Zone/part of room where filling of sterile products or other

sterile processes take place.

• Controlled area: Room / area where the product is formulated filled and
sealed.

4. Federal Standard 209E and British Standard 5295 lay general guidelines for clean rooms.

5. The new ISO 14644 standards shall probably be the future working document for

designing all clean rooms, since the standard is industry-specific, describing standards

for the hospital sector, food industry, pharmaceutical industry and electronics industry.

Bio-clean Rooms
Rooms that are germ free room or which have fewer microbes than general areas are referred to

as bio-clean rooms. Normally, in order to create such environments, high-performance HEPA air

filters are used. These air filters are capable of trapping 99.97 percent of 0.3-micron particles, and

even bacteria are trapped in these air filters. The typical organisms of concern are:

Note that the ‘Rickettsias and Viruses” are smaller than the size of particles that can be trapped in

the HEPA filters. In reality these organisms are not floating in the air in single units (rickettsias live

inside insects, and viruses attach to dust floating in the air). Therefore if insects and dust can be

eliminated it is possible to ensure a biologically clean environment in the room. The cause of

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