Air Filters for The Pharmaceutical Cleanroom

The pharmaceutical industry has become one of the most developed sectors in recent times. Progressive advancements in science and technology have helped this industry grow. The pharmaceutical industry is one of the most heavily regulated manufacturing firms. Quality management systems have a direct impact on the ultimate quality of finished products. 

Because of the significance attached to pharmaceutical industries, just like food industries, they are directly used by consumers, either for local application or internal consumption. To ensure the high quality, safety, and efficacy of pharmaceutical products, manufacturing units need to follow all the standards set by the regulatory authorities. Otherwise, the products might deteriorate the consumer’s health. 

Pharmaceutical cleanrooms are necessary to prevent contamination and ensure consistent drug quality. Cleanrooms are classified according to the number of particles per cubic meter at a specified particle size. The FDA regulates pharmaceutical cleanrooms and requires that they meet certain standards for design, construction, use, and testing. The FDA also sets requirements for the certification of pharmaceutical cleanrooms.

The pharmaceutical manufacturing industry has multiple processes that take place in cleanrooms. The pharmaceutical manufacturing unit follows a series of steps to produce effective medicines. All these points are crucial, and the total production process will be completed only when all these steps in production are perfectly completed.

The manufacturing steps hold design conception, withdrawal, dispensation, manufacture, alteration, liberation, packaging, and storage. 

And additional processes include:

Formulation: The process of creating a drug substance into a final product form

[Compounding pharmacies prepare personalized prescription medications from individual ingredients mixed together in the exact strength and dosage required.

Compounded medications can include capsules or tablets, creams, or gels, and injectables. Because the risk of infection is greater with injectables, they must be prepared according to strict standards established by the Indian Pharmacopoeia

Commission (IPC) regulations for compounding sterile products.
Based on these standards, the air in the compounding area must meet ISO Class 5 standards for clean air, which specify the number of particles permitted per cubic meter of air, to prevent microbial contamination that could cause infection in patients. Containment air filtration systems are essential to ensuring an environment free of dangerous microbial contaminants for compounding drugs safely.

Containment filtration systems are designed, developed, and manufactured to exact standards for control of microbial contamination in compounding pharmacies. High quality, customized total containment filtration systems manufactured by a single source ensure maximum performance reliability in adherence with required ISO Class 5 standards for clean air.
AAF specializes in the design, manufacturing, and testing of complete, custom containment filtration systems incorporating HEPA filters with maximum filtration efficiency for a virtually particulate-free environment to prevent contamination of compounded drugs.]

Fill/Finish: The process of taking the drug substance and filling it into the final container

Primary Packaging: The process of placing labels on the final drug product container for sale to the consumer

Secondary Packaging: The process of putting drug products into display packages such as boxes used for sale to consumers.

The Food and Drug Administration (FDA) has also set up strict requirements on air purity levels within the pharmaceutical industry to minimise the threat of airborne contamination to the quality of both prescription and over-the-counter medications. Especially for aseptically prepared parenteral medicine, such as injectables and infusions, no degree of contamination is acceptable, as severe harm or even life-threatening risks to the patient can result. 

No clean air is possible without a carefully selected and reliably functioning air filtration system. The performance of installed air filters, whether terminal filters or prefilters, or HEPA filters/ ULPA filters, directly figures out how effectively harmful contaminants are prevented from entering the airstream in process environments.

Under normal operating conditions, the air inside the pharmaceutical production facility may have: 

  • Molds, spores, pollen, bacteria, and viruses
  • Carbon monoxide, radon, volatile organic compounds (VOCs)
  • Bacteria, viruses, and byproducts
  • Vehicle engine exhaust, exhaust from industrial plants
  • Asbestos, clay, elemental particles, and synthetic fibres

However, if the air filter selection process doesn’t consider, the lifetime operating costs of a given product, facilities could be exposed to unnecessary risks and unexpected expenses. 

 Improve Your Environment By Improving Your Filtration.

A thorough air filter audit of your HVAC systems is the first step that AAF takes, to provide you with professional guidance and analysis for cost savings and liability reduction. By conducting this audit, we strive to understand your current state and your complete air filtration needs, applications, and goals for total air quality. This customized air filtration survey costs you nothing and could give you significant benefits by helping you save money, reduce risk, and save time. 

Contact your American Air Filter representative to learn more about the wide range of products & services that will help clean air and minimise risk and maximise operational efficiency. 



MEGAcel ® II eFRM HEPA Filter

Designed specifically for the unique requirements and challenges of life science industries, the MEGAcel II mini-pleat HEPA filter has superior durability, compatibility with polyalphaolefin (PAO), high particulate filtration efficiency, and the lowest pressure drop

VariSorb® XL15

VariSorb® XL15 Gas-Phase Box Filter

VariSorb® XL15 a complete solution to Indoor Air Quality (IAQ) by providing high level filtration of both odors and particulates.

VariCel® VXL

VariCel® VXL Box Filter

VariCel® VXL can be used in high velocity systems, operating at up to 3.8 m/s (750 FPM)



MEGAcel® II ePTFE ULPA filtration technology provides at least 30% lower initial resistances than conventional microfiber media, resulting in unrivaled fan energy consumption reductions.

MEGApleat® M8

MEGApleat M8

MEGApleat M8 offers a unitized, die-cut box, beverage board frame with double thickness on the perimeter wall. The MEGApleat M8 filter is extremely strong and durable under difficult operating conditions, including high-moisture applications

AmAir®-C Filters

AmAir®/C Filter Family

AmAir/C, AmAir/C+SAAFOxi, and AmAir/SAAFOxi filters are housed in a frame made of moisture-resistant, high-wet-strength beverage board. These filters provide cleaner air for a longer period.

VariCel® RF-C & RF-C-SAAFOxi

VariCel RF/C and RF/C +SAAFOxi

The VariCel RF/C and RF/C +SAAFOxi filters are extended-surface rigid air filters for the removal of gaseous pollutants, odors, and particulates.

VariSorb® XL

VariSorb XL

The VariSorb XL filter is designed to improve indoor air quality through the effective removal of indoor and outdoor gaseous contaminants, including VOCs, SOx, NOx, and Ozone.

VariSorb® XL15

VariSorb XL15

VariSorb XL15 high-efficiency filters are designed to improve indoor air quality through the effective removal of indoor and outdoor particulate and gaseous contaminants typically found in the urban environment.

VariSorb® HC

VariSorb HC

The VariSorb HC filter is designed for the effective removal of common indoor and outdoor gaseous contaminants to help mitigate indoor air quality problems.

Universal Holding Frame

Universal Holding Frame

Universal Holding Frame​ are designed to exclusively work with the Universal Holding Frame retaining tab

AstroCel II

AstroCel II

AstroCel® II HEPA filter available in efficiency classes H13 – U16.

AstroFan FFU EC

AstroFan FFU -EC

AstroFan FFU – EC is a low energy consumption HEPA module.


Bag In/Bag Out HEPA Module

The AAF Bag In/Bag Out Side Access filter system is a safe, simple, reliable method for removing contaminated particulate filters and/or gas absorbers used for air purification in hazardous environments.


TMRSC Module

TM II is available with microfibre glass HPEA or ULPA media


CR II Clean Room Ceiling Module

This HEPA module is designed for operating theatre, providing laminar airflow.


Air Filter Audit

Complete Filter Analysis: Air Filtration Audit

A thorough air filter audit of your HVAC systems is the first step that AAF takes, in order to provide you with HVAC energy analysis for cost savings. In this way, we identify how your filtration system can optimally perform. Contact us to find out more about lowering your HVAC cost.


Total Cost of Ownership Made Clear: TCO Diagnostic®

TCO Diagnostic, which is customized to your HVAC total cost of ownership, provides a clear insight into the optimal filtration options and tailors to your demands for a full clean air solution – enhancing air quality, energy savings, and operational flexibility while lowering your life cycle costs.

Get In Touch with AAF
AAF India Pvt Ltd

Contact: +91 944 875 1680