COMECER - Manufactures Isolation Technologies

For more than 40 years, COMECER has been a worldwide leading company in the design, manufacturing and integration of state of the art Isolation Technology Systems (glove boxes, RABS) for the Pharmaceutical and Biotech industries.

Comecer isolation team delivers customized turnkey solutions with a flexible approach in a total in house organization. The advanced design and construction methods ensure cleanability, durability and ease of use. Comecer provides a full range of solutions for containment and aseptic processing from R&D to commercial scale and quality control applications. We can supply stand-alone units as well as isolation lines that are integrated with production machinery used in pharmaceutical laboratories such as autoclaves, vacuum ovens, mixer, filters, reactors, granulators, scales, as well as, in other production filling lines, dedusters, and metal checks.

COMECER (Headquarters)
Via Maestri del Lavoro
48104 Castelbolognese, Italy
Phone:+39 0546.656375
Fax: +39 0546.656353
E-mail: comecer@comecer.com

Isolation Technology Technical Specifications

• All of the internal angles have a radius of curvature of 20mm to facilitate the cleaning and sterilization operations.
• All welds are ground, smoothed, and polished.
• All stainless steel components are welded using TIG method.
• Sliding Doors are made with interlock and inflatable gasket.

Applied Standards
Design and qualification are in accordance with the following reference standards and guidelines:

• GMP (Good Manufacturing Practice)
• ISO 14644 (Cleanrooms and associated controlled Environments)
• ISO 10648 (Containment enclosures)
• PDA – TR Nr 34 (Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products)
• GAMP5 (Guide for Validation of Automated Systems)
• CFR 21 Part 11 (Electronic records; electronic signatures)

Easy Cleanning

• Automatic or manual solutions available
• All components are suitable for aseptic applications
• The isolators can be dried using hot air (supplied by a dedicated HVAC)
• All piping and tubing are self-draining
• Fully automated recipes (washing + drying)

Events: INTERPHEX New York (USA) March 29th - 31st Stand No. 3133 Visit us at Booth 3133 for demonstrations of our newest products: The Modular Sterility Testing Isolator and The Automatic Glove Tester

Comecer AGT (Automatic Glove Tester) Demonstrated At INTERPHEX At INTERPHEX 2011, Loris Rinaldi of Comecer demonstrates the AGT (Automatic Glove Tester). It is used to test glove integrity in conformity with the pressure decay method ISO 14644-7 Annex E.5 (test in positive pressure). The AGT can test a maximum of 12 gloves simultaneously.