The Medical, 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:
21 CFR 177.2600 for elastomers
• (EU) 1935/2004
• 3-A sanitary standards 18-03 and 20-27
• USP Class VI and Chapter and
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 The European Hygienic Engineering and Design Group (EHEDG), The World Health Organisation, The American Society of Mechanical Engineers, The Fluid Sealing Association, The ISO
, The Health & Safety Executive, The NSF and The Federal Drug Administration.
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 Rubber Sheet
0731 EU1935, FDA, BGA White Nitrile Rubber Sheet
0621 EU1935, FDA
, BGA White Neoprene Rubber
0157 EU1935, FDA, BGA White EPDM Rubber Sheet
5396 EU1935, FDA
, BGA Blue Nitrile Rubber
, BGA, WRAS, USP Class VI Platinum Cured Silicone
J202 Glass Filled PTFE Jointing meeting FDA & USP
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:
Encapsulated O Rings
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.