Can Your Seals Handle Pharma Manufacturing Conditions? 

by:Pragati Verma

Manufacturing drugs was never an easy process – and new breakthroughs such as biologics, gene therapies, and complex large molecule drugs are making it harder. The increasing complexity has led to the use of harsher chemicals and aggressive cleaning processes that in turn have placed increased demands for chemical resistance on the components used in the pharma equipment.  

FDA Class VI-Compliant Seals  

As pharmaceutical manufacturers grapple with these challenges, they are upgrading their equipment with components made of materials that can withstand the rigors of the new harsh environment and meet FDA (Food and Drug Administration) and USP VI (United States Pharmacopeia Class VI) compliance where required.  

Consider seals, such as O-rings, for instance. When exposed to aggressive chemicals and steam-in-place cleaning and sterilizing applications, seals made of traditional materials might degrade or corrode and thus compromise drug quality and potentially pose a risk to patient safety.   

In contrast, sealing solutions made of FDA Class VI FFKM materials, such as Chemraz® SD625 and Chemraz® SD 517, meet the highest standards of safety and compatibility with pharmaceutical processes. “These materials not only resist corrosion and degradation but also maintain their integrity over prolonged exposure to harsh chemicals and steam in both static and dynamic applications,” says Richard Dilorio Jr., Industry Expansion Manager at Greene Tweed, “Our components are integral to a diverse array of pharmaceutical processing equipment, including filter-dryers, chromatography columns, crystallizers, centrifuge, lyophilizers, mixer-blenders, pumps, and valves.”  

Class VI certification demonstrates compliance with the highest pharmaceutical-grade standards, according to United States Pharmacopeia. Seema Gangatirkar, product manager for industrial Chemraz® at Greene Tweed explains why: “Compliance to this standard ensures that no harmful reactions or long-term issues are caused to the body by chemicals used in the manufacturing process with digestible as well as injectable drugs. Moreover, the material must exhibit a very low level of toxicity and biocompatibility through three extensive tests to ensure conformance to USP <87>and USP <88>.  The mandatory testing to test biological reactivity includes systemic injection test, intracutaneous test, and implantation test.”   

Contamination-Free Drugs and Vaccines  

It’s not hard to see why confidence in the quality of materials and processes is essential in the pharma industry where manufacturing is a sensitive process that often takes place in protected cleanroom environments.   

One such critical process is chromatography, essential for purifying and isolating key components of drugs. According to Richard, Greene Tweed’s Chemraz® SD 625 seals enabled a leading COVID-19 vaccine manufacturer to ramp up production of their lifesaving vaccine in late 2020. Conventional sealing materials couldn’t stand up to harsh chemical environments and rigorous sterilization procedures in their chromatography columns. By upgrading to FDA Class VI Chemraz® SD 625 seals, the manufacturer could streamline their production operations. The enhanced durability and chemical resistance of the seals minimized downtime, enabling continuous operations at scale.  

The vaccine manufacturer is not alone. A large biomedical company struggled with leakages in an encapsulated drum seal in its filter dryer used to manufacture one of their best-selling drugs. They turned to Greene Tweed’s FDA Class VI Chemraz® SD517 seals and the new robust sealing solution successfully stopped leaks and the resultant contamination from previous seal degradation, safeguarding the integrity of the medicine under production. In addition to enhanced chemical resistance, the upgraded sealing solution was able to minimize downtime associated with equipment maintenance and replacement.   

Explaining why Greene Tweed FDA Class VI materials provide near universal chemical resistance and an excellent service lifetime in steam-in-place applications Seema says, “Our seals are manufactured and packaged in an ISO 7 cleanroom, ensuring low particulates and extractables. This ensures that they maintain performance in cleaning reagents and sterilant.”  

Are your pharmaceutical manufacturing operations becoming more complex and demanding? Please reach out to a Greene Tweed representative to explore how sealing solutions made of our FDA Class VI FFKM materials can ensure the safety and efficacy of your medicines.