Moorfields cleans up with disposable manufacturing system
Moorfields Pharmaceuticals has introduced a disposable manufacturing system, thereby reducing time and costs by eliminating the need for equipment cleaning and associated cleaning validation.
Moorfields selected the LevTech WandMixer Disposable System which uses disposable bags without seals or bearings, including ‘wand’ for mixing. Once the manufacturing process and the bulk solution passed through a sterilizing filter, the entire bag is fully disposable. The disposable system is supplied sterile which makes a positive contribution to reducing the bioburden that sterilizing filters are exposed to.
The reduction in cleaning and validation time provides a reduction in downtime and cost benefit which can be passed on to customers.
Says Technical Director, Nick Precious, “Moorfields concentrates on small contracts, with batch sizes of 1 to 25,000 for vial presentations. The introduction of disposable mixing enables us to offer a faster, more cost-effective service for these small orders without compromising our high levels of quality.”
A LEADING EDGE MANUFACTURING FACILITY
Moorfields Pharmaceuticals has invested in a purpose built state-of-the-art manufacturing facility below ground, close to London’s financial district. The manufacturing unit is designed to meet the needs of a UK and European customer base and provides the following production capability:
Bausch and Strobel Filling Machine KSF1020 for fully automated vial filling. Protected by a Class A environment with a Class B background, vials can be aseptically filled on this equipment or terminally sterilised post-filling.
Precision Sterile Hand Filling. Semi-manual filling is performed under a Class A environment, with a Class B background. Baxa filling pumps are used to achieve the required filling accuracy whilst the filled vials are sealed with an automated crimping unit or cap applicator.
Rommelag 3012M. 3012M is the newest and most significant addition to their portfolio, and provides a high level of sterility assurance. With the ability to produce as few as 5,000 ampoules, the Rommelag offers the ideal solution for production of preservative-free ophthalmic drugs and sterile liquids for Phase 1 clinical trials.
All this is supported by comprehensive analytical services, a complete documentation service and a qualified person review and release of batches. All products are manufactured to GMP standards, in accordance with MHRA licenses and the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007.
October 2009
PR CONTACT: Lyn Wallace or kate Jones on +44 (0)20 8995 5354 or lyn@wallacehcl.com
EDITOR`S NOTES
Moorfields Pharmaceuticals is the pharmaceutical manufacturing facility of Moorfields Eye Hospital, one of the world’s leading ophthalmic hospitals providing expertise in clinical care, research and education.
Moorfields has prepared pharmaceutical products in response to clinical needs for over 50 years but in the 1990s it was identified as a revenue generating opportunity for the hospital.
In 2003 a purpose-built manufacturing facility was opened on a separate site next to Moorfields Eye Hospital.
MHRA licenses were awarded in 2004.
Moorfields Eye Hospital was awarded Foundation Trust status in April 2004 and Moorfields Pharmaceuticals was established as an autonomous business unit.
