Sastel Pharmaceuticals was established by Johann and Lienta Roelofse in 1993. Johann Roelofse is the Executive Member and is an electronics engineer and pilot with a master’s degree in project management. Lienta Roelofse is the Marketing Manager and responsible for the research and development of products for new and existing clients. She qualified as a scientist with a HED and honours in science education. She is currently registered as a Pharmacist Assistant at the South African Pharmaceutical Council.
The original company acted as a wholesale distributor of orthodox medicine which distributed its products to pharmacies and doctors. The vision of the company changed over years and got more involved with Complementary and Alternative Medicine (CAMS).
Sastel Pharmaceuticals then expanded into Sastel Packaging in order to include the manufacturing and packing of cosmetics and foodstuff including powders and liquids. The company was registered in 2006 with the Department of Health and is also a member of the Health Product Association (HPA) to keep track of regulations, developments and client requirements.
During the years, our facility has been renovated to implement the logic flow as required by GMP. More air-conditioning and a HVAC system were installed. Customised software were developed and implemented to accommodate, regulate and control documents and processes for GMP. From a product batch number, all information of the product, like manufacturing conditions, operators involved and specific API’s with batch numbers and CoA's can be traced.
In the beginning of 2010 a Quality Management System was implemented. In October 2010 Sastel achieved certification in a QMS (ISO9001) and expanded it to certification in a Environmental Managed System (ISO14001) and Occupational Health and Safety Management System (OHASA18001) to form a Integrated Management System (IMS).
The Quality Assurance Manager is responsible to maintain and upgrade the IMS. a Number of Quality Control Inspectors execute the standards and requirements of the IMS on the production floor.
To comply with GMP and IMS requirements, an in-house laboratory was set up in 2011. The laboratory is responsible to sample under laminar flow conditions, identify and approve all raw materials received by the Goods Receiving department before accepted in the Approved Raw material store.
The development and training of human resources is a priority of Sastel. In co-operation with the Chemical Seta (CHIETA) and Sastel’s in-house skills development plan, A big investment was made to establish an in-house training facility. Employees are trained through in house training material, presented by an in-house trainer and external consultants.
Courses vary from basic skills development right through to degrees in Further Education Facilities.
Sastel is proud of its performance and track record over the last 20 years. We are committed to assure the client with professionally manufactured and packed products according to GMP regulations in order to assist the client to claim quality, quantity and efficacy of their products.
The company has since taken on the role of a "Family Owned Business" with Johann and Lienta's children; Cara and Cornell joining the company in 2014 and 2016 respectively. Cara obtained a BSc in Chemistry at the University of Pretoria and a Coschem diploma from the Society of Cosmetic Scientists with the special award of "Best Student" in both first and second year. She is our Laboratory Technician and also responsible for the research and development of cosmetic formulations. Cornell's keen eye for specifics makes him perfect to act as first line of quality control in our Goods Receiving Department, ensuring nothing but high standard materials are taken in.