Containment Facilities

Facility B

Facility B was commissioned in September 1996 and included as part of an FDA inspection in May 1998. It is used primarily for the manufacture of cytotoxic active ingredients for parenteral use and manufactures cytotoxic products on a scale of between 1 and 10kg. Products manufactured to date include those for the US market and for Phase I and II clinical trials.

Facility B is a containment facility for the production of anticancer (cytotoxic) APIs. It contains two plant rooms - an upstairs plant room containg 60L reaction vessels and a downstairs plant room containing 250L reactors . The facility is segregated into separate rooms for isolation of intermediates and separation of process streams. The plant is extremely versatile and additional vessels can be added depending on the process taking place. Reaction vessels are jacketed, glass-lined stainless steel or jacketed glass vessels. Process pipework, filters and pumps are made from inert materials, and intermediates and final products are isolated in either Nutsche-type filters or centrifuge.

Complex multistage chemical reactions are conducted. Manufacture can be confined to either the small scale plant room or the lower larger scale plant room, or both the upstairs and downstairs reactors can be used simultaneously with product being fed to downstairs from above.

The facility contains a number of additional rooms for product filtration, centrifuging, oven drying, dispensing, packaging and for operator decontamination. The facility is designed with a series of small rooms such that if there is a spillage, it is confined to a small area.

The entire facility is maintained under Class 3500 (US Class 100,000) conditions. It is designed to retain the product handling areas under negative pressure. These negative pressure rooms are surrounded by positive pressure rooms, to prevent airflow into the facility and thus protect the product from the environment, and vice versa. The air handling is single pass air.

Operators are fully gowned in tyvec suits, gloves, overshoes and respirator hooked to a breathing air supply. This is primarily to prevent exposure to cytotoxic materials. Often the reagents used, or the by-products in the process, are more toxic than the cytotoxics produced in the facility. When using large quantities of solvents operators wear rubber suits for added protection.

All waste generated in the facility, including the rinse water used for showering the suits worn by operators, is incinerated to prevent cytotoxics entering the drainage system.

Other Facilities

Facilities E, K, L and R each contain small cleanroom containment facilities designed for manufacture of highly toxic materials such as cytotoxics, hormones and cephalosporins.

The type of chemistry performed in these facilities is laboratory-style synthetic chemistry using laboratory glassware, and is conducted under Class 3500 (US Class 100,000) conditions within fumehoods.