Tuesday, October 24, 2006

Metal detector system meets all 21 CFR regulations

Pharmaceutical metal detector system is believed to be the first and only one that meets all requirements of the 21 CFR regulations, including IQ OQ qualifications.

The new THS/PH21 is the first and only Pharmaceutical Metal Detector System to have been specifically developed to meet all requirements of the 21 CFR regulations, including IQ OQ qualifications. The THS/PH21 is not an upgrade to existing apparatus, both the machinery and software have been designed and manufactured from the ground up to conform to current and future Pharmaceutical Quality Assurance standards. Developed by CEIA and available in the UK solely through Constant Instruments , the THS/PH21 construction complies with 21 CFR requirement Part 210 - current good manufacturing practice in manufacturing, processing, packaging or holding of drugs and Part 211 - current good manufacturing for finished pharmaceuticals.

New software complies with regulation Part 11 - security, integrity and traceability of production data so that electronic records and electronic signatures can be produced.

The THS/PH21 has extremely high detection sensitivity of 0.3mm diameter ferrous, non-ferrous and stainless steel metals and features an innovative deflector for precise ejection of a contaminate at high flow rates.