Chemotherapy Isolator

Tender description

This specification covers the requirements for the Pharmacy Aseptic Services department at the Queen Elizabeth Hospital, Gateshead. The Trust has a requirement to purchase a Rigid negative pressure isolator with ISO 14644 Class 4.8 (EC GMP Grade A) unidirectional (laminar) air flow ergonomically designed for one operator to safely and aseptically handle cytotoxic products and other hazardous materials. The products present a health and safety risk to the operator but also must be handled under aseptic conditions to maintain sterility and minimise risks of contamination. The equipment offered must meet the following design standards of compliance: • BS EN ISO 14644-7: 2004 - Clean rooms and associated environments - Separative devices • EC GMP Grade A (ISO 14644-1:1999, Class 4.8) - Air classification in controlled workspace • BS EN 1822-1: 1998 - All HEPA filters • BS EN 12469: 2000 - All HEPA filter seals • BS EN 61010-1: 2001 - All Electrical wiring. Supply 230V/50Hz/1Ph • ‘Pharmaceutical Isolators’, Pharmaceutical Press 2004 - Guidance document This project involves the design, manufacture, delivery, installation, testing and commissioning of the Isolator. Departmental Manager – David Sproates Tel: 0191 445 2316