The Pharmaceutical Industry requires their systems to comply with medicinal production regulations referenced and abbreviated as EP, BP, USP and PICS.
Depending on the use of the purified water it could either be classified as Purified Water (PW) or Water for Injection (WFI), which will impact the system’s design and the technology considered.
Vicol uses the ISPE (International Standards for Pharmaceutical Engineering) guidelines as design basis for our pharmaceutical system applications, combined with current Good Manufacturing Practice (cGMP) and the requirements of the Medicine Control Council (MCC) for the production of medicinal products.
Our experience in designing and installing storage and distribution facilities complying with the requirements for hygienic design as stipulated by the authorities mentioned above, is unrivalled in South Africa.
Another very important aspect of systems required for medicinal production is the complete validation of these systems and components, Vicol uses in-house experts for the validation of these systems, including Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification, with PQ normally conducted as a joint venture with the customer.
As with our systems offered to the Food and Beverage Industry, we maintain a “zero substance added” approach, this essentially means that the selected treatment process and the system cleaning processes will minimise the requirement for addition of any foreign matter to the product recipe, which in turn ensures:
- the risk of product contamination is significantly reduced
- the impact of the plant on the immediate environment is reduced as no corrosive chemicals are used
- Downtime is significantly reduced as no flushing of chemicals and chemical traces is required.
Vicol offers the following treatment processes to the Pharmaceutical Industry
- Twin stage Reverse Osmosis
- RO-EDI (Electro-deionisation)
- Distillation