![]() While the testing of such solutions may be meaningful in determining the bioburden for sterilization, it does not provide any information regarding the potential formation or presence of endotoxins. In some cases, manufacturers have performed bioburden testing on bulk solutions after prefiltration and prior to final filtration. Good practice for the compounding of lyophilized products would also include batching in a controlled environment and in sealed tanks, particularly if the solution is to be held for any length of time prior to sterilization. ![]() The concern with any microbiological level is the possible increase in endotoxins that may develop. Obviously, the batching or compounding of these bulk solutions should be controlled in order to prevent any potential increase in microbiological levels that may occur up to the time that the bulk solutions are filtered (sterilized). However, some of the other dosage forms that are lyophilized, such as hydrocortisone sodium succinate, methylprednisolone sodium succinate and many of the biotechnology derived products, have no antibacterial effect when in solution.įor these types of products, bioburden should be minimal and the bioburden should be determined prior to sterilization of these bulk solutions prior to filling. Because they are antibiotics, low bioburden of these formulations would be expected at the time of batching. Many of the antibiotics, such as some of the semi-synthetic penicillins, cephalosporins, and also some of the salts of erythromycin, doxycycline and chloramphenicol are made by the lyophilization process. Products are manufactured in the lyophilized form due to their instability when in solution. This discussion will address some of the problems associated with the manufacture and control of a lyophilized dosage form. Some of the important aspects of these operations include: the formulation of solutions filling of vials and validation of the filling operation sterilization and engineering aspects of the lyophilizer scale-up and validation of the lyophilization cycle and testing of the end product. It is recognized that there is complex technology associated with the manufacture and control of a lyophilized pharmaceutical dosage form. In order to provide guidance and information to investigators, some industry procedures and deficiencies associated with lyophilized products are identified in this Inspection Guide. Additionally, inspections have disclosed potency, sterility and stability problems associated with the manufacture and control of lyophilized products. ![]() There are many new parenteral products, including anti-infectives, biotechnology derived products, and in-vitro diagnostics which are manufactured as lyophilized products.
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