The Pharmaceutical and Healthcare Industry face challenges to maintain cleanliness, traceability and compliance to stringent quality requirements.
The range of applications and operating conditions within the Pharmaceutical and bio-processing equipment market presents a challenging role for any sealing materials and seal products supplier to deliver an effective and comprehensive portfolio.
Working within this environment requires attention not only to the stringent regulations and quality control of the sealing materials, production processing and packaging, but also to the complexity of the operations within which the seal is required to perform during both the critical manufacturing of compounds but also the post production sterilisation programmes.
Whilst many sealing products are designed for single use and will be changed out following each production cycle others will need to demonstrate effective seal performance through repeated cycles - typical factors being non-degradation of material which could lead to contamination of the process; resistance to microbial growth; resistance to chemical sterilisation or autoclaving; non-leaching of constituent elements such as oils or waxes.
Meeting the increasingly rigorous regulations requires innovation, technical knowledge and persistence to develop the right product. This will typically come through collaboration with the clients technical team, equipment manufacturers design team, or through discussion with the controlling technical body to develop achievable targets for improvement in the material standards.
MacLellan Rubber constantly reviews the current and future technical standards involving sealing products published by international regulatory bodies, including:
• FDA 21 CFR 177.2600 for elastomers
• (EU) 1935/2004
• 3-A sanitary standards 18-03 and 20-27
• USP Class VI and Chapter <87> and <88>
• NSF/ANSI standards 51 and 61 for food equipment materials
Maintaining a clear vision of the needs of the industry by observing the activities of International organisations and industry associations such as:
Our extensive range of high quality products which are utilised within this hygiene critical industry include the following gasket materials:
0128 EU1935, FDA, BGA White Natural Rubber
0731 EU1935, FDA, BGA White Nitrile Rubber
0621 EU1935, FDA, BGA White Neoprene Rubber
0157 EU1935, FDA, BGA White EPDM Rubber
EU1935, FDA, BGA Blue Nitrile Rubber
EU1935, FDA, BGA, WRAS, USP Class VI Platinum Cured Silicone Rubber
Gylon® 3504 - from Garlock Sealing Technologies - meets FDA and USP requirements
Dupont™ VIton® GF-600S - meets FDA and USP 28 Class VI
Non Asbestos Fibre Jointing
Complementing the above materials we also offer the following sealing products:
Tank Lid Seals
As a supplier of highly engineered safety critical Technical Sealing Materials and Products we offer a high level of engineering support to ensure that the right material option is selected for the application whether that is hygienic pipework, blenders and mixers, fluid bed dryers, valves or pumps. We engage with our customers in a variety of ways, from onsite technical support and advice to product training and installation. Our expertise in engineering solutions that are practical, effective and efficient is widely recognised by our customers across Europe, the Middle East, Africa and Asia- our supply relationships encompass onsite stock holding, same day deliveries and rapid manufacture of seals.
MacLellan Rubber continues to invest in the development of new materials and sealing solutions and partners with world class businesses around the globe to offer innovative solutions that ensure our materials, seals, gaskets, and diaphragms meet the key market needs with excellent chemical resistance, long service life and performance that guarantees the integrity and reproducibility of your product.