Precision Associates Inc has been a leading manufacturer of close tolerance moulded rubber seals, O-Rings, and other products since 1955. Capabilities include an in-house tool shop, and mould design for quick prototyping of injection, compression, and transfer tools, compound development and material test lab, and a 6000 square foot Class 7 Clean Room located within our 130,000 square foot rubber moulding facility.
We specialise in homogeneous thermoset rubber and rubber bonded to metal and/or plastic inserts. Our manufacturing capabilities include product size ranges from 36 inches to micro-miniature like the World's Smallest O-ring. This O-Ring measures .004 cross-section by .004 inside diameter (0.1 mm x 0.1 mm).
Material selection is a critical step in producing a successful seal and customers put their trust in our compounds. Precision Associates has over 1000 formulations and if necessary, technologists in our laboratory can develop a recipe from over 20 polymer groups including, FKM, FEPM, FFKM, EPDM, NBR, HNBR, and silicone. We have materials that meet REACH, RoHS, Prop 65, ADI Free, Conflict Free requirements.
PAI manufactures a number of compounds that are suitable for use in medical applications requiring body or body fluid contact. These materials have been tested by independent laboratories or our material suppliers to assess their ability to meet requirements as defined by several standards organisations.
Precision Associates' medical compounds are tested per the United States Pharmacopeia (USP) which sets the standard for medicines and other health care products manufactured or sold in the USA. PAI rubber compounds have been tested to meet USP <87> and <88> Biological Reactivity Test for Class VI materials. Additionally, PAI USP VI compounds are formulated with materials sanctioned under the Federal Code of Regulations, Title 21, Part 177.2600. Each lot undergoes physical property testing. Many of these same materials also pass ISO 10993-5, (vitro cytotoxicity) -10 (irritation and skin sensitization) and -11 (systemic toxicity) testing as well.
In addition to meeting all of the requirements of the USP VI Grade materials, Biomedical Grade silicone elastomers undergo additional biocompatibility testing including implantation. Each lot is screen strained to remove particulate contamination and is subjected to tissue culture testing. Biomedical grades are suitable for use in the same applications as USP VI materials and for short term implantation up to 29 days. Silicone grades suitable for long term implantation are also available. Each application must be approved by Precision Associates and our material manufacturer prior to purchase.
Medical grade products are produced and packaged in our ISO 14644-1 Class 7 certified Clean Room. Although manufacture takes place in a clean room, it is not a sterile environment. PAI medical grade materials may be sterilized by EtO, autoclave, or gamma radiation.
Proudly certified ISO 9001:2015, our processes are designed to produce high quality parts. All production is lot controlled to ensure that traceability is maintained throughout the manufacturing process. Each lot of rubber parts is 100% visually inspected by people or automated video inspection machines for defects prior to shipment so you can be assured that only the best products arrive at your door.
Turn to Precision Associates when you need parts quickly! We carry an extensive number of seals available for immediate shipments. Need something special? We have thousands of moulds and our short lead time to produce parts is industry leading!
