Pharmaceutical facilities, sometimes referred to as Life Sciences or Bio-pharma, have their own set of air quality factors when considering the proper air filter to apply in their manufacturing processes. Application requirements range from efficiencies of MERV 8 prefilters to HEPA filters, and unique air filter configurations from special high temperature air filters to industry specific cleanroom modules. Important air filter selection considerations include sustainability and energy savings, landfill impact, total cost of ownership and meeting the requirements of Standards for air quality as published by cognizant authorities. Two additional concerns that are paramount are protecting employees and ensuring the purity of the pharmaceuticals produced at the facility.
In the United States the Food & Drug Administration (FDA) provides guidance and regulation to the pharmaceutical industry. Various standards and publications such as the Current Good Manufacturing Practice (cGMP) ensure that items that make it to the drug store shelves perform as expected. Some facilities include high level labs defined as Bio-Safety 1 (BSL-1) through Bio-Safety 4 (BSL-4) where extreme precautions are required to isolate dangerous biological agents within an enclosed area. The levels are classified by the Centers for Disease Control (CDC) in the United States and a directive from the European Union in Europe. There is even a professional organization, the American Biological Safety Association (ABSA) that includes over 1,600 members. The lower BSL level ensures a setting for working with items of moderate hazard to personnel and the environment (low level bacteria such as E. coli) to the highest level that includes dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections (Ebola, hemorrhagic fever, etc.). These BSL-4 level contaminants can cause severe to fatal disease in humans for which vaccines or other treatments have not yet been developed.
Drug producing facilities have a variety of areas that include different cleanliness requirements including:
- Aseptic processing that includes:
- Wash and Prep areas that require prefilters, high efficiency ASHRAE air filters and HEPA filters
- Sterilizer Prep that incorporate prefiltration and high temperature HEPA filters
- Aseptic Filling that use HEPA filter ceiling modules
- Restricted Access Barrier Systems (RABS) that use HEPA filter ceiling modules
- And Packaging which will also use HEPA filter ceiling modules
- Oral Solid Dosage (OSD) facilities that include:
- Gowning areas that use HEPA filter ceiling modules to ensure cleanroom worker cleanliness
- Compression Suites that require specialized air filtration modules using HEPA filters and containment modules to protect employees from potent compounds
- Compaction/Milling areas that use prefiltration, HEPA filters and in some cases containment level housing to control contaminants of concern
- Coating areas that use HEPA filtration
- Isolator areas that use specialized air filtration, usually HEPA filters, incorporated within specialized processing equipment
- And Down Flow Booths incorporating HEPA filters as the final barrier of protection for employees and the product
Some areas even require dust collection equipment based upon the volume of airborne particles produced by the process or gaseous air filters such as carbon or oxidizers to remove odors or noxious contaminants. Most facilities have administrative or commercial offices within the structure requiring air filtration to ensure the protection of the employees in those areas.
Without air filters we would not have even the basic pharmaceutical necessities. Air filters for pharmaceuticals should be selected for a guaranteed level of particle removal efficiency throughout the life of the filter, economies of operation that include long life and maintained low resistance to airflow, a low impact on the environment and adherence to the intricacies of ASHRAE filter testing Standard 52.2 (including MERV-A), EN779, IEST performance parameters and ISO 29463. It is also expected that the air filter manufacturer be ISO 9001:2008 compliant.
ASHRAE Standard 52.2 – American Society of Heating Refrigeration and Air-Conditioning Engineers “Method of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size,” including Appendix J, available athttp://www.ashrae.org
EN 779 – European Air Filter Test Standard, available at http://www.en-standard.eu/
IEST – Institute of Environmental Sciences and Technology, Recommended Practices CC001, CC002, CC006, CC007, CC012, CC034 and others, available at http://www.iest.org
ISO – International Organization for Standardization documents ISO 29463-1, ISO 29463-2, ISO 29463-3, ISO 29463-4 and ISO 29463-5 available at http://www.iso.org