Aseptic Medical Devices COMPANY INFORMATION SHEET AMD Aseptic Medical Devices Who we are and what we do Pouches are qualified and validated for gamma sterilisation and impermeability to Alcohols and VHP, yet are soft, flexible and easy-linear-tear. It is the aim of AMD to ensure devices utilised in the compounding of drugs are: •The best devices for the application are made available to all scales of compounding manufacturing •Are optimally packaged for ease of QC, use and transfer into the LAF or Isolator •Our validation and qualification is industry leading AMD provides optimised compounding procedure packs which include: •BD Syringes •Encapsulated Needles •Filters & Filter needles •Vial access devices & vented Chemo pins •Closures and Combi-stoppers Items and combinations are available from individual unit cleanroom packaging (Alcohol and VHP impermeable) right through to packs large enough to support bulk manufacture. Aseptic Medical Devices Newmarket Drive, Derby DE24 8SW +44 (0) 1332 755622 [email protected] www.asepticmedical.com Cytotoxicity and endotoxin qualification takes these products into a league of their own in terms of GMP compliance. AMD is part of Riverside Medical Packaging Over the past 30 years, Riverside Medical Packaging has established itself at the forefront of the healthcare industry. We have increasingly developed intelligent and innovative solutions to satisfy the demanding requirements for producing, packaging and sterilising single use medical Riverside’s state of the art 2500sq metre manufacturing facility has been tailormade specifically for the manufacture of medical packaging and products. It houses 7 Cleanrooms (two Class 8 and five Class 7), each being either process or product specific. AMDCINF/0514 WHO WE ARE At the heart of the products is one of our core areas of expertise - packaging. AMD Packaging is made available in PeroxyClear and PeroxyMet - making preuse QC of the contents rapid and accurate. AMD - Who We Are As our name strongly suggests AMD manufacture and provide medical devices in a format designed exclusively for one application, namely for the production of aseptically manufactured pharmaceuticals. Aseptic Medical Devices COMPANY INFORMATION SHEET AMD Aseptic Medical Devices WHO WE ARE AMD - Who We Are These superb manufacturing cells, BSI/ ISO accreditation and creative R&D team enables us to provide a diverse, innovative range of high performance products at an economical price regardless of quantity. Specialist knowledge of drug compounding and GMP cleanroom operation, has lead to the development of a turn-key offering from AMD of non-device sterile consumables including sterile 70% alcohols with water for injection - triggers sprays and impregnated wipes, together with mopping systems and safety products such as chemo gloves, needle de- and re-sheathing devices, cleanroom ‘chemo’ & ‘sharps’ bins and absorbent mats. Built on a foundation of excellence and traceability, success is measured through the highest levels of customer satisfaction. Aseptic Medical Devices Newmarket Drive, Derby DE24 8SW +44 (0) 1332 755622 [email protected] www.asepticmedical.com AMD is BSI accredited to ISO 9001:2008 & ISO 13485:2003 All orders received pass through our stringent contract review procedure to ensure that exact customer requirements are met. Manufactured products and packed devices are 100% inspected. In addition they may be subjected to quality checks which are customer or product specific. The company holds CE accreditation for Class I sterile devices and a number of Class IIa medical devices. We process some of the most advanced medical packaging materials available in the world. Pouches and sachets are regularly checked on-line for conformance to specification and seal integrity. Off-line seal strength, burst and die penetration testing is routinely carried out on pouches, sachets and blisters in accordance with EN 868 Part 1. AMDCINF/0514