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Additional info for Pharmaceutical Dosage Forms: Tablets, Second Edition, --Volume 3
1 mL containing approximately 106 spores. coli endotoxin at a level of 10,000 ng/unit. 6 Load to be validated will be described in the validation report. __. 2 Heat penetration and distribution study, and biological/pyrogenic challenges will be performed simultaneously. Data will be recorded at ten minute intervals. __. 6 At completion of each cycle, remove the biological indicators and endotoxin samples and send them to the biology laboratory for testing. 7 Run three cycles. Figure 18 Dry heat sterilization/depyrogenation cycle validation process.
Verify that necessary documentation has been completed, signed, and dated by authorized, responsible personnel. To reduce the risk of microbial contamination due to equipment mishandling, the following good manufacturing practices should be followed: All equipment should be dismantled and cleaned after each lot; coupling nuts on pipework and valves should be taken apart and parts cleaned after each lot; the product should be protected from any lubricant used on moving parts; agitator blades, preferably of one piece with the shaft, should be cleaned after each lot; a separate sampling outlet should be installed on the bulk tank beside the runoff valve to avoid the risk of microbial growth; a new set of filters must be used for each lot; and all surfaces in direct contact with the product should be smooth, continuous, and free from pits with all junctions rounded or coved and the welds polished with no dead ends.
An example of a dry heat sterilization/depyrogenation validation protocol is shown in Figure 18. There should be a quality assurance system in place that requires revalidation periodically and whenever there are significant or major changes in manufacturing process, equipment, formulation, or product attributes. Room 1X 5 5 5 3 5 1X = Once Per Shift 2X = Twice Per Week CFU = Colony Forming Unit Figure 16 Microbial monitoring in aseptic areas. RODAC Floor Walls Air Sampler Equipment (# CFU/Plate) (Biotest RCS) # CFU/FT3* *Calculated Page 32 PURPOSE: To demonstrate the ability of the air conditioning system to control temperature at 72 ± 20°F.