The Production block has been designed in accordance with the requirements of WHO Good Manufacturing Practices for Sterile production. Due to the critical nature of our products which are required to be sterile, there are adequate measures in place to ensure that microbial and particulate contamination of the various rooms and the products are kept to the barest minimum. The design also ensures logical flow of materials and personnel.
Clean rooms for the manufacture of these large volume sterile products have been classified according to the required level of environmental cleanliness both at rest and in the operational state. Since these products are to be terminally sterilized, the filling operations are undertaken in a Class 100 (Grade A) unidirectional airflow workstation, a Non-PVC Form-Fill-Seal machine against a Class 10,000 (Grade C) background.
Blow Fill-Seal Machine Setup
Brief Description of the Manufacturing Process
The process of infusion manufacture commences with the production of water for injection (WFI) which serves as the main vehicle in with other raw materials are dissolved. The new plant has an installed Water treatment Plant that combines a Double–Pass Reverse Osmosis, Electrodeionization and Ultrafiltration mechanisms in the production of WFI. Following weighing of the specified amount of raw materials, mixing is carried out with the WFI to produce concentrate which is subsequently diluted to produce a final homogenous solution. The latter is then pumped for filling in Polypropylene bags and sealed by the Form-Fill-Seal process. Autoclave sterilization of the pre-filled infusion bags is then carried out, the products are inspected for visible particles and leakages, and are finally packaged in BOPP/polythene (as secondary package) and then in cartons.
The Form-Fill-Seal Process
This involves three main stages namely, Label printing & container moulding; container filling; and container sealing.