MAIN PAGE ABOUT ATTO CAREER PRODUCTS CONTACT

 

 

Air Pollution Control

Automotive

Bio-Pharmaceutical

Commercial Buildings

Facilities Management

Food & Beverage Processing

Hospitals & Health Care

Laboratories

Microelectronics

Museums

Nuclear

Power Systems

Residential

Railroad

Schools

 

 

 

 

 

 

 

 

 

 

Bio-Pharmaceutical

The US Food and Drug Administration (FDA) has published Federal Regulation 21 CFR Part 820, Quality System Regulation. This regulation follows ISO 9000. More specific to the clean areas and cleanrooms of interest are the standards and drafts under ISO 14644.   A good overview of these standards is available on the IEST web site. Similarly, European Standards provide European Nations with guidelines for GMPs.

Why do these GMPs matter with regard to air filtration in pharmaceutical, bio-pharmaceutical, and medicinal products manufacturing processes? Because GMPs require that the quality of these products be assured, including the control of product contamination during manufacturing and packaging. Generally speaking, the control of contamination is most critical for injectable or parenteral preparations as compared with topically applied or orally ingested preparations. Eye drops, which can be considered a topically applied preparation, are an exception to this rule as they eye is quit susceptible to infection.

 

Join Our Newsletter

Medium Efficiency Filters
High Efficiency Filters
Very High Efficiency Filters
Molecular Filters
Filter Housings & Systems
Power System Filters
Railroad Filtration
Air Pollution Control Filters & Equipment
High Temperature Filters
Painting Booth Filters
Containment Systems

 

 

ATTO for Industrial & Petroleum Limited Services 2009