Aseptic processing operation presented by sai dhatri arige v. This two day summit features expert insight into the robust aseptic processing requirements facing the industry. Eudralex the rules governing medicinal products in the european. A process by which environmental or equipment bioburden is reduced to a safe level or eliminated. Any manual or mechanical manipulation of the sterilized drug. Previous version dated 30 may 2003, in operation since. Sterilization equipment should be designed to facilitate easy manual operations by the operator. Thus the manufacturer is therefore reliant upon a good contamination control strategy. To assess the risks of nonsterility each organization should develop a contamination control strategy. Contaminants of water 1 there is no pure water in nature, as it can.
Establishing a contamination control strategy for aseptic. Batchprocessing records and, in the case of aseptic processing. Aseptic and non pathogenic biological product containment in aseptic processing of sterile medicines, drugs and drug substances. The process of producing a sterile product by aseptic processing is either through. Guidance on the manufacture of sterile pharmaceutical products by aseptic processing 3 environment is commonly referred to as grade b.
Bioburden contamination control is a critical aspect of pharmaceutical, medical device and personal. This requires an assessment, acknowledgement and remediation process for contamination risks. Pdf establishing a contamination control strategy for. Establishing a contamination control strategy for aseptic processing. The contamination control plan in facility validation. There shall be separate or defined areas or such other control systems for the firms operations. Conclusion references download the powerpoint by liking us. It should be controlled and for aseptic processing it should be. With both, a product is sterile filtered into a sterile container sterile stainless steel vessel or plastic. Annex 1 1 manufacture of sterile medicinal products 2 document.
Guidance on the manufacture of sterile pharmaceutical. Continuing on with the theme of microbial exclusion from the aseptic core. Sterile pharmaceutical products by aseptic processing. Guidance for industry sterile drug products produced by aseptic processing current good manufacturing practice u.