Particles smaller than 10 microns may be invisible to the human eye, but their presence can prove hazardous in the manufacture of parenterals and other biotech products- so hazardous, in fact, that the FDA's aeseptic processing guidelines mandate a minimum Class 100(ISO 5) cleanroom for critical areas, which are defined as anywhere parenterals may be exposed.

Further, the critical areas must be supported by a minimum Class 10,000 (ISO 7) cleanroom throughout the rest of the controlled facility although many manufacturers today are even opting for the stricter Class 1,000 (ISO 6). Under the burden of such heavy regulations—not to mention the threat of personnel and end-user safety risks—parenteral manufacturers must continuously evaluate their housekeeping regimens to ensure that all controlled areas are properly cleaned and maintained. The first step in any such evaluation is to scrutinize the most critical cleaning function carried out in biotech and other cleanrooms: vacuuming.

Vacuuming with cleanroom-compatible machines designed specifically to collect and retain microscopic particles enables you to prevent airborne particulate contamination, ensure air and product purity, and safeguard the health of employees.

To fully realize these benefits one must ask some key questions:

• What are the most common cleanroom contaminants in biotech facilities? How can they be prevented from entering the cleanroom?

• How do other cleanroom cleaning methods stack up against vacuuming?

• Which is best—a central system, several portable vacuums, or a combination of both?

Keeping Contaminants Out

First, let’s take a look at common cleanroom contaminants and how they can be prevented from entering the cleanroom in the first place. Contaminants are typically generated by two major sources: materials/equipment and cleanroom personnel (see Figure 1).