Sector
Throughout each stage of pharmaceutical manufacture, contamination elimination, traceability and compliant sealing materials are critical.
Pharmaceutical
Pharmaceutical manufacturing is divided into two major stages. The first stage, typically referred to as primary processing or manufacture, is the production of the active ingredient or drug. The second stage, secondary processing, is the conversion of the active drugs into products suitable for administration.
Throughout each and every stage, the importance of contamination elimination cannot be overlooked.
With pharmaceutical sealing, materials need to demonstrate chemical compatibility, high temperature resistance, abrasion resistance and the capability to withstand aggressive cleaning regimes. Seal robustness requirements are very high, for example in tablet production where powders are processed.
During the production of chemically produced drugs, API (Active Pharmaceutical Ingredients) or in vivo diagnostics such as contrast agents and biomarkers, chemicals and toxic substances are used. Organic synthesis can involve high temperatures and high pressures, while cooling and low temperatures occur during precipitation of the product.
USP Class VI and FDA grades are available for EPDM, FFKM, Viton® / FKM, Silicone and PTFE. FDA grades are available for Nitrile and HNBR.
In today’s pharmaceutical and bio-pharmaceutical industries, cleanliness, traceability and compliance with international regulatory standards, including FDA and USP regulations, are essential for risk management. Durable, high-performance and precisely engineered sealing solutions are imperative to meeting these goals and preventing process material contamination.
In the pharmaceutical industry, batch processing tends to be the norm. This ensures traceability from the raw material supplier to the patient in the event of quality issues. It is therefore critical that seals comply with increasingly stringent material quality and production standards.
To ensure the hygiene and purity of a batch, special attention must be paid to process documentation. It is important to know the ingredients of sealing materials, or to have appropriate confirmation of biocompatibility according to USP Chapter 88 (Class VI).
Pharmaceutical and bio-pharmaceutical equipment represents a wide range of applications and operating conditions. Sealing solutions must meet key operational needs with excellent chemical resistance and optimise performance across a diverse range of media.
Metal detectable O-Rings help reduce the risk of product contamination by early detection and containment. They decrease the risk of polymers finding their way into the finished product and supply chain.
As elastomer seals degrade, there is an increased risk of rubber fragment contamination. Metal detectable O-Rings are manufactured from Silicone, Nitrile, EPDM and FKM compounds, and are available in blue or black for easy product identification and extended lifetime performance.
Encapsulated O-Rings, also known as FEPs and PFAs, are recommended when a standard O-Ring has inadequate chemical resistance and a solid PTFE O-Ring does not have the elasticity for reliable, long-term fluid sealing. Encapsulated O-Rings have either a Viton® or Silicone core, with a spring version available for cryogenic applications.
Spring O-Rings are ideal for sealing at extremely low temperatures where traditional elastomers suffer from brittleness. Low compression sets allow effective sealing as low as -250°C in cryogenic applications. Spring O-Rings use a precision rolled flat strip spring in 301 stainless steel (AMS 5519N), formed to energize a seamless jacket of fluoropolymer (FEP or PFA).
Inflatable seals offer unique mechanical and chemical properties for pneumatic sealing challenges in pharmaceutical applications. These seals have hollow profiles sealed to be air tight, allowing individual pressure to be applied to varying seal gaps.
They are suitable for sealing airlock doors and hatches, dome valves and sterilising equipment. Inflatable seals can unseal and inflate, making the process more efficient where gaskets or re-clamped components would otherwise need to be re-bolted.
Eastern Seals supply dependable, compliant seals that meet key operational needs with excellent chemical resistance and long service life. We recognise the demands of the Pharmaceutical industry are constantly changing, and as a responsible supplier, we offer materials to comply with regulations and requirements including FDA and EU legislation.
We offer a full range of O-Rings from standard materials to metal detectable and USP Class VI seals. Our FEP encapsulated O-Rings are also fully compliant to requirements stipulated in FDA and EC Regulation for materials and articles intended to come into contact with products manufactured for the Pharmaceutical industry.