The pharmaceutical industry is responsible for providing viable cures and lifesaving treatments through drugs and vaccines.
The pharmaceutical industry is at the heart of the healthcare ecosystem that ensures people’s health and wellbeing through critical research, drug tests, discovery, sales and distribution. To ensure 100% safety of medicines and vaccines, the pharmaceutical industry must adopt state-of-the-art cleanroom technology and equipment.
Although India is a global leader in affordable generic drugs and vaccine manufacturing, home to nearly 500 APIs manufacturers, the industry is governed by stringent USFDA and applicable local regulations. Setting up a pharmaceutical manufacturing site involves complex and sensitive production processes vulnerable to cross-contamination and airborne particulate matter like dust, pollen and microbes. Contamination breach can be detrimental in many ways, including
- The production processes and the products itself (drugs, vaccines etc.,) may be compromised resulting in huge losses. Regulators may prohibit sales.
- Inferior drugs administered to the general population might result in fatalities. Regulators and authorities can file criminal proceedings and even revoke licences.
- Inferior drugs can result in negative consumer sentiment. Loss in market share, consumer confidence and erode brand value.
- Without proper contamination control measures, drug discovery, clinical trials and go-to-market strategies may face setbacks.
- Most importantly, pharmaceutical manufacturing companies must regularly demonstrate (at least once in 6 months) compliance to ISO 14644-1 cleanroom cleanliness classification in terms of permissible particulate count and other controlled parameters. If not, “Non Conformity” during periodic audits can lead to licences being revoked.
Alpha Linear continues to assist the pharmaceutical industry for over 3 decades in delivering its commitment through safe and innovative cleanroom designs and contamination control equipment for the further advancement of this sector.
Our range of equipment fit for pharmaceutical applications include,
