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.
Contact: +91 944 875 1680