WHO WE ARE
The name Kwalisa is derived from the isiZulu word UKUGCWALISA, meaning “to fill”. Kwalisa Sterile Filling was established in 2015 and is a cGMP accredited pharmaceutical contract manufacturing facility specialising in the production of aseptically sterilised pharmaceutical injectables for local and international clients. Kwalisa Sterile Filling was the first in Africa to use a fully automated robotic aseptic filling system that is flexible and responsive to client requirements. The automated system can adapt to cater for small, potentially hazardous products ranging from 1 to 2000 sterile injectables per batch.
OUR VISION AND MISSION
Kwalisa Sterile Filling endeavours to be an internationally approved cGMP manufacturing facility that provides unique, batch specific, specialised injectables, including highly potent or toxic medicines, aimed at individual or small group patients.
We pride ourselves in efficient manufacturing of products to meet client requirements for quality, safety and efficacy while providing excellent yields and short response times. Our fully robotic VanRx SA25 filling isolator provides a world class environment for cGMP aseptic filling. The VanRx SA25 has in-process controls that provide a high degree of automated environmental monitoring (viable and non-viable particulate monitoring). With this fully robotic work cell, our services include:
- Manufacture of pre-registration clinical trial batches
- cGMP sterile vial manufacturing