Aseptic

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Dr. Raju Jukanti Aseptic Processing Operation St. Peter’s Institute of Pharmaceutical Sciences Kakatiya University, Warangal-506 009, A.P

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Introduction Sterile manufacturing operations Terminal sterilization and Aseptic processing operations Terminal sterilization – product, container, and closure have a low bio-burden but are not sterile Aseptic processing - Sterile products, which cannot receive a post filling lethal treatment because the product, container cannot withstand terminal sterilization treatments. Aseptic processing the drug product, container, and closure are subjected to sterilization processes separately and then brought together in clean room environment to create the finished product.

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Minimizing the risk of microbiologic contamination during aseptic processing by employing clean room environments, sterilization validation programs, microbiologic environmental monitoring programs, simulations of sterile processing operations, and personnel training. Sources of microbial contamination in Aseptic processing Personnel borne contaminants Human error Non–routine operations during aseptic process Assembly of sterile equipment prior to use Mechanical failure Inadequate or improper sanitization Transfer of materials within APA Routine operations during aseptic process Airborne contaminants Surface contaminants Failure of sterilizing filter Failure of HEPA filter Inadequate or improper sterilization

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Contamination Control Airborne contamination Manufacturing systems and facilities that control or minimize exposure to airborne microorganisms can minimize the risk of microbiologic contamination during aseptic processing operations. Maintenance of a hygienic laboratory Frequent disinfection of floors and surfaces Minimizing the traffic in and out of the area Use of laminar air flow devices Use of water with excellent quality and free from microbial contamination. HEPA Filters Aseptic manipulations in laminar airflow units with HEPA filters. FDA recommends the use of HEPA filters at critical locations in aseptic manufacturing operations.

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Testing HEPA filtered Laminar airflow systems Leak test (DOP test) Air flow velocity (Hot wire anemometer) Airflow pattern (Titanium tetrachloride smoke sticks) Protective Garments Sanitization and facility design Personnel Training Sterilization Systems

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Types of Laminar Air Flow Cabinet

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Environmental Monitoring Methods

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Microbiologic Environmental Monitoring Microbiologic testing of Water Testing the microbiologic quality of the Air Identification of microorganisms Anaerobic culture conditions Air Particulate Monitoring Characterization of Aseptic processes Media fill test (Soybean casein digest broth) Microbiologic contamination rate in aseptic manufacturing operation - Concentration of airborne microorganisms. - Neck area opening of the container being filled. - Length of time the container remains open.

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Media commonly used for environmental control

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Quality and shelf life of any product depends on presence and nature of m.o contained in it. Under favourable conditions these m.o proliferate and result in loss of product quality. Microbiological monitoring is an essential part of Q.C. Bacteriological analysis of water is periodically done and the tests are performed. Standard plate count Detection of coliform bacteria Presumptive coliform count Differential coliform count Membrane filteration method

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Modern approach Dip slides : For detection of Bacteria, Yeast, Fungi

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Thank U