The business of Fine Chemicals Corporation was established in Cape Town, South Africa in 1962. The company operated initially as Petersen Chemicals for the purpose of manufacturing Active Pharmaceutical Ingredients (API's). The move to the current site took place in 1975. Initially, products including Codeine Phosphate, Morphine Sulphate and Paracetamol were targeted at the local South African market and in the mid 1980's a range of off patent generic API's were developed in-house. These were largely destined for the US market.
The production facilities at Fine Chemicals Corporation (FCC) are divided into 10 production buildings, each of which is managed by a Production Supervisor. The total production processing area under roof inclusive of mezzanines amounts to 6965m2. The raw materials and finished goods stores comprise a further 3388m2. The total site area is 2,7ha/27000m2. The production facilities operate on a three-shift basis dependent on current demand.
The firm observes twelve public holidays per annum and traditionally closes for an annual shutdown of approximately three weeks during December and January to enable staff to benefit from the continuous statutory vacation period of fifteen working days.A comprehensive, ongoing health, safety and environmental programme has been structured to ensure the safety of employees and compliance with the recent changes in the relevant legislation. Where justified by volume, some production buildings are dedicated to the manufacture of a single product or product range for the domestic market eg Narcotics. Most other buildings contain multipurpose production plant that provides a high level of flexibility. The production facilities are located in buildings of brick and steel construction. Cement floors are coated with acid resistant epoxy cement resin.
Walls in process areas are plastered to a smooth finish and painted with an acrylic paint. Epoxy paint is used in finishing areas. All service lines and electrical cables are housed in bulkheads and sheet-metal trunking, respectively. Reaction vessels, heat exchangers and tanks are generally located above floor level on structural mezzanines, while filters, pumps and centrifuges are located below the mezzanines at floor level. Drying, granulating, milling, blending, micronising and packaging are carried out in separate areas.
The Quality Control Laboratory function complies fully with cGMPs and is capable of performing virtually all testing in support of the product range. Facilities consist of: General laboratory with facilities for carrying out standard analytical operations such as titrations, solvent extractions, distillations, melting point determination, Karl Fischer automatic titrations, ash content, loss on drying, thin layer chromatography, etc. Instrument rooms house gas and liquid chromatographs, headspace sampler gas chromatographs, UV/visible, IR and fluorescence spectrophotometers, thermogravimetric analysis equipment, an electronic polarimeter and a Malvern droplet and particle size analyser, Balance room, Laboratory offices Storage room for retention of samples, glassware and laboratory equipment, Wash-up area.