Sastel Pharmaceuticals was established by Johann and Lienta Roelofse in 1993. 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 Packaging have expanded its manufacturing capabilities to include the manufacturing and packing of cosmetics and foodstuff including powders and liquids.

 

Johann Roelofse is the executive member and is an electronics engineer and pilot with a master’s degree in project management.

 

Lienta Roelofse is responsible for marketing, research and development of products for clients of the company. She qualified as a scientist with a HED and honours in education. She is currently registered as a Pharmacist Assistant at the South African Pharmaceutical Council.

 

Sastel Pharmaceuticals was registered in 2006 with the Department of Health. Sastel is also a member of the Health Product Association (HPA) to keep track of regulations, developments and  client requirements.

 

Sastel employs a pharmacist which is registered as its Responsible Pharmacist with the SAPC. Sastel have a Deputy Pharmacist and three registered Pharmacist Assistants to support the Responsible Pharmacist.

 

After some time the building was 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. The laboratory is responsible to sample under laminar flow conditions, indentify 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 higher education facilities.

 

Sastel is proud of it performance and track record over the last 20 years and is committed to assure its clients professional manufacturing under GMP to assist its clients to claim quality, quantity and efficacy of their products.

 

(CaraCertJRLR)