培养基灌装验证(英).doc

Media Fill Validation - SVP 1.0 INTRODUCTION An aseptic processing operation should be validated using microbiological growth medium in place of the product. This process simulation, also known as a media fill, normally includes exposing the microbiological growth medium to product contact surface of equipment, container closure system, and critical environments to closely simulate the same exposure that the product itself will undergo. The sealed containers filled with the medium are then incubated to detect microbial contamination. 2.0 OBJECTIVE: The Objective of this protocol is to establish documented evidence that the process employed for aseptic processing of Parenterals liquid/Ophthalmic solution will produce the desired results consistently, within the specified acceptance limits, when performed as per the latest Standard Operating Procedures. 3.0 SCOPE: The Validation protocol describes the procedure for the total Process Simulation (Media Fill) for SVP line. 4.0 RESPOSIBILITIES: S. No. Responsibilities Name of the Department 1 Preparation of Protocol QC 2 Provision of qualified personnel to assist in the protocol preparation and Execution QC, QA, Production and Maintenance 3 Verification of Protocol QC and Production 4 Approval of protocol QA 5 Final determination of System Acceptability QA 6 Review and assembling of data into a final report QA 5.0 PREREQUISITES Approved Soybean casein digest broth Aseptic area gowning procedures and Entry into sterile areas. Environmental Monitoring of manufacturing areas by Plate Exposure, Air sampling and surface monitoring procedures and its SOP’s. Personnel Monitoring by Finger Dab Swab Test Method its SOPs. Qualified and validated manufacturing equipments, system facility (i.e. HVAC, water, compressed gases) CIP and SIP procedures. Trained operating personnel’s. Approved BMR for media fill trial. 6.0 EQUIPMENT / SYSTEM DESCRIPTION: Location : Manufacturing Area SVP 3012 line (Mixing room and filling room