Chemical Process Technologies Pharma
Chemical Process Technologies Pharma (Pty) Ltd (CPT Pharma) commissioned an API pilot plant facility in Waltloo, Pretoria. The API Pilot Plant is designed to be current Good Manufacturing Practice (cGMP) compliant and is in the process to be approved by the South African Health Products Regulatory Authority (SAHPRA) previously, the Medicine Control Council (MCC). The Pilot Plant will be used for the scale-up of Active Pharmaceutical Ingredient (API) production processes, and the manufacture of batches for stability testing that are required for regulatory registration purposes.
One of the objectives of CPT Pharma is to make the plant available for external users.
Equipment and infrastructure
The pilot plant has the following equipment:
- 200 L stainless steel jacketed reactor with condenser for reflux and distillation.
- 400 L stainless steel jacketed reactor with condenser for reflux and distillation.
- 250 L glass lined jacketed reactor with condenser for reflux and distillation.
- 400 L glass lined jacketed reactor with condenser for reflux and distillation.
- Acid resistant 300 L enclosed filter system.
- 50 kg Vacuum oven.
- Cone mill for particle size manipulation.
- Piping between reactors has been designed to allow several different configurations of connection for content transfer.
The Pilot Plant has the following utilities and infrastructure:
- Purified water conforming to the US Pharmacopoeia standard.
- Class D loading and work-up areas, accessible via Material and Personnel airlocks.
- Nitrogen blanketing on reactors.
- Recovery of solvents by distillation.
- Temperatures of between 0 and 130 °C can be achieved and maintained independently by each reactor.
- Vacuum for drying and distillation. Up to -85 kPa vacuum is possible.
- Scrubbing of off-gasses.
External users can benefit from the CPT Pharma Pilot Plant regarding the following services:
- The scale-up of API production processes in a cGMP environment.
- The manufacturing of API batches for stability testing, that is required for regulatory registration purposes.
- To manufacture API material under cGMP conditions for clinical trials.
- Transfer technology; the use of the pilot facility to fast track the in-licensing of technologies (particularly Antiretroviral API’s) that require an existing cGMP facility before a license agreement can be negotiated.
- To manufacture small volume API’s on a commercial basis.
- The CPT Pharma team is available to assist with the operation of the pilot plant, cGMP training and Hazop planning and training for any external projects.
Contact details for further information
- Dr Hannes Malan
+27 12 803 5907 or +27 82 801 3632;
- Dr Gerrit van der Klashorst
+27 12 803 5907 or +27 82 607 0402;
CPT Pharma in the news
Pilot Plant opening on 10 November 2017
CPT A Very Active Ingredient in June 2018
Photo credit: Atelier Topo