Perl - Pharma Engineering Resolutions Ltd

PERL is a Contract Engineering company providing Pharmaceutical and Biotechnology facilities with engineering support and expertise. Our specialist knowledge will allow the set up or improvement of engineering systems to achieve increased production efficiency and meet increasing regulatory pressures. Our aims are to deliver smarter, leaner, cost effective engineering solutions to ensure reliable quality compliant systems. OUR SERVICES We can provide you with the following services and expertise; • Design of Planned Preventative Maintenance Systems • Project management of system installation • Resource for routine and demand maintenance and calibration activities • Equipment validation support • Development of Policies and Procedures EXAMPLES OF PREVIOUS PROJECTS • Project management to implement a new qualified IMS system and improvements to existing BMS system for a leading Biopharmaceutical manufacturer. • Implementation of maintenance systems and calibration schedules requiring full instrument categorisation, including a suite of new procedures for a contract filling facility, achieving MHRA audit and for a Biopharmaceutical facility for audit approval. • Calibration and maintenance engineering support for a manufacturing Biotechnology facility in the Midlands during routine shutdowns. • Writing of engineering calibration SOPs and policies for a Biotechnology company which achieved FDA approval. • Validation of equipment and utilities at a Pharmaceutical facility in Israel including gap analysis, identifying deficiencies in existing qualifications, protocol writing, execution and review, resulting in 2011 FDA approval. • Annual service contract for maintenance and calibration of clean room isolators for the NHS.