Tajamul Manzoor’s Post

𝗛𝗮𝘃𝗲 𝗬𝗼𝘂 𝗘𝘃𝗲𝗿 𝗪𝗼𝗻𝗱𝗲𝗿𝗲𝗱 𝗛𝗼𝘄 𝗪𝗲 𝗦𝗲𝗹𝗲𝗰𝘁 𝘁𝗵𝗲 𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗦𝗲𝘁𝘁𝗹𝗲 𝗣𝗹𝗮𝘁𝗲𝘀 𝗶𝗻 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗖𝗹𝗲𝗮𝗻 𝗥𝗼𝗼𝗺𝘀? 𝘐𝘯 𝘵𝘩𝘦 𝘱𝘩𝘢𝘳𝘮𝘢𝘤𝘦𝘶𝘵𝘪𝘤𝘢𝘭 𝘪𝘯𝘥𝘶𝘴𝘵𝘳𝘺, 𝘦𝘯𝘴𝘶𝘳𝘪𝘯𝘨 𝘵𝘩𝘦 𝘢𝘪𝘳 𝘲𝘶𝘢𝘭𝘪𝘵𝘺 𝘪𝘯 𝘤𝘭𝘦𝘢𝘯 𝘳𝘰𝘰𝘮𝘴 𝘪𝘴 𝘷𝘪𝘵𝘢𝘭 𝘧𝘰𝘳 𝘱𝘳𝘰𝘥𝘶𝘤𝘵 𝘴𝘢𝘧𝘦𝘵𝘺 𝘢𝘯𝘥 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘤𝘰𝘮𝘱𝘭𝘪𝘢𝘯𝘤𝘦. 𝘚𝘦𝘵𝘵𝘭𝘦 𝘱𝘭𝘢𝘵𝘦 𝘵𝘦𝘴𝘵𝘪𝘯𝘨 𝘱𝘭𝘢𝘺𝘴 𝘢 𝘤𝘳𝘶𝘤𝘪𝘢𝘭 𝘳𝘰𝘭𝘦 𝘪𝘯 𝘦𝘷𝘢𝘭𝘶𝘢𝘵𝘪𝘯𝘨 𝘢𝘪𝘳𝘣𝘰𝘳𝘯𝘦 𝘤𝘰𝘯𝘵𝘢𝘮𝘪𝘯𝘢𝘵𝘪𝘰𝘯 𝘣𝘺 𝘢𝘭𝘭𝘰𝘸𝘪𝘯𝘨 𝘮𝘪𝘤𝘳𝘰𝘰𝘳𝘨𝘢𝘯𝘪𝘴𝘮𝘴 𝘵𝘰 𝘴𝘦𝘵𝘵𝘭𝘦 𝘰𝘯 𝘢𝘯 𝘢𝘨𝘢𝘳 𝘱𝘭𝘢𝘵𝘦 𝘰𝘷𝘦𝘳 𝘢 𝘴𝘱𝘦𝘤𝘪𝘧𝘪𝘤 𝘱𝘦𝘳𝘪𝘰𝘥. 𝗦𝗼, 𝗵𝗼𝘄 𝗱𝗼 𝘄𝗲 𝗰𝗵𝗼𝗼𝘀𝗲 𝘁𝗵𝗲 𝗿𝗶𝗴𝗵𝘁 𝗹𝗼𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝘀𝗲𝘁𝘁𝗹𝗲 𝗽𝗹𝗮𝘁𝗲 𝘁𝗲𝘀𝘁𝗶𝗻𝗴? 𝗛𝗶𝗴𝗵 𝗧𝗿𝗮𝗳𝗳𝗶𝗰 𝗔𝗿𝗲𝗮𝘀: We focus on locations with high personnel movement, such as entry points, gowning areas, and workstations. These areas are more prone to contamination, making them essential monitoring points. 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗭𝗼𝗻𝗲𝘀: Areas where open products, containers, or equipment are exposed are selected for monitoring. These zones are directly involved in the production process, and any contamination here could compromise product sterility. 𝗔𝗶𝗿𝗳𝗹𝗼𝘄 𝗣𝗮𝘁𝘁𝗲𝗿𝗻𝘀: Understanding the airflow dynamics within the clean room is key. We select locations based on airflow studies, often placing settle plates near air supply or return points to monitor the effectiveness of air filtration systems. 𝗘𝗾𝘂𝗶𝗽𝗺𝗲𝗻𝘁 𝗣𝗹𝗮𝗰𝗲𝗺𝗲𝗻𝘁: Equipment can be a source of contamination or disrupt airflow patterns. Therefore, settle plates are often placed near key equipment to monitor their impact on air quality. 𝗛𝗶𝘀𝘁𝗼𝗿𝗶𝗰𝗮𝗹 𝗗𝗮𝘁𝗮 𝗮𝗻𝗱 𝗥𝗶𝘀𝗸 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁: We also rely on past data and risk assessments to identify potential hotspots for contamination. Historical trends and any deviations observed in routine monitoring help refine the locations for settle plate testing. 𝘈𝘤𝘤𝘰𝘳𝘥𝘪𝘯𝘨 𝘵𝘰 𝘵𝘩𝘦 𝘗𝘋𝘈 𝘛𝘦𝘤𝘩𝘯𝘪𝘤𝘢𝘭 𝘙𝘦𝘱𝘰𝘳𝘵 𝘕𝘰. 13 (𝘛𝘙 13), "𝘛𝘩𝘦 𝘭𝘰𝘤𝘢𝘵𝘪𝘰𝘯𝘴 𝘰𝘧 𝘴𝘦𝘵𝘵𝘭𝘦 𝘱𝘭𝘢𝘵𝘦𝘴 𝘴𝘩𝘰𝘶𝘭𝘥 𝘣𝘦 𝘣𝘢𝘴𝘦𝘥 𝘰𝘯 𝘢 𝘳𝘪𝘴𝘬 𝘢𝘴𝘴𝘦𝘴𝘴𝘮𝘦𝘯𝘵 𝘤𝘰𝘯𝘴𝘪𝘥𝘦𝘳𝘪𝘯𝘨 𝘵𝘩𝘦 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭 𝘤𝘰𝘯𝘵𝘢𝘮𝘪𝘯𝘢𝘵𝘪𝘰𝘯 𝘴𝘰𝘶𝘳𝘤𝘦𝘴, 𝘤𝘳𝘪𝘵𝘪𝘤𝘢𝘭 𝘱𝘳𝘰𝘤𝘦𝘴𝘴𝘪𝘯𝘨 𝘢𝘳𝘦𝘢𝘴, 𝘢𝘯𝘥 𝘱𝘦𝘳𝘴𝘰𝘯𝘯𝘦𝘭 𝘮𝘰𝘷𝘦𝘮𝘦𝘯𝘵 𝘱𝘢𝘵𝘵𝘦𝘳𝘯𝘴." 𝘛𝘩𝘪𝘴 𝘢𝘭𝘪𝘨𝘯𝘴 𝘸𝘪𝘵𝘩 𝘵𝘩𝘦 𝘨𝘶𝘪𝘥𝘢𝘯𝘤𝘦 𝘱𝘳𝘰𝘷𝘪𝘥𝘦𝘥 𝘣𝘺 𝘜𝘚𝘗 <1116>, 𝘸𝘩𝘪𝘤𝘩 𝘦𝘮𝘱𝘩𝘢𝘴𝘪𝘻𝘦𝘴 𝘵𝘩𝘢𝘵 𝘮𝘰𝘯𝘪𝘵𝘰𝘳𝘪𝘯𝘨 𝘴𝘩𝘰𝘶𝘭𝘥 𝘣𝘦 𝘧𝘰𝘤𝘶𝘴𝘦𝘥 𝘰𝘯 𝘢𝘳𝘦𝘢𝘴 𝘸𝘩𝘦𝘳𝘦 𝘤𝘰𝘯𝘵𝘢𝘮𝘪𝘯𝘢𝘵𝘪𝘰𝘯 𝘳𝘪𝘴𝘬 𝘪𝘴 𝘩𝘪𝘨𝘩𝘦𝘴𝘵. By strategically selecting these locations, we ensure a comprehensive evaluation of clean room. 𝗥𝗲𝗳𝗲𝗿𝗲𝗻𝗰𝗲𝘀: USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments; PDA Technical Report No. 13 (TR 13).

Selection of Growth Media: (USP <1116>) . A general microbiological growth medium like TSA (Tryptic Soy Agar) is suitable for environmental monitoring in most cases because it supports the growth of a wide range of bacteria, yeasts and molds. . This medium can be supplemented with additives to overcome or to minimize the effects of disinfectants/sanitizing agents or of antibiotics. . Manufacturers should consider the specific detection of yeasts and molds. . IF NECESSARY, general mycological media such as SDA (Sabouraud’s Dextrose Agar) or inhibitory mold agar can be used. . In general, monitoring of strict anaerobes is not performed, because these organisms are unlikely to survive in ambient air. . The ability of any media used in environmental monitoring, including those selected to recover specific types of organisms, must be evaluated for their ability to support growth i.e. should be evaluated by growth promotion test.

Repeat Sterility Testing: USP <71> states: . If evidence of microbial growth is found, the product to be examined does not comply with the test for sterility, unless it can be clearly demonstrated that the test was invalid for causes unrelated to the product to be examined. . The test may be considered invalid only if one or more of the conditions are fulfilled: 1.     The data of the microbiological monitoring of the sterility testing facility show a fault. 2.     A review of the testing procedure used during the test in question reveals a fault. 3.     Microbial growth is found in the negative control. 4.     After determining the identity of the microorganism isolated from the test, the growth of this species (or these species) may be ascribed unequivocally to faults with respect to material and or the technique used in conducting the sterility test procedure. ·        If the test is considered invalid, it is repeated with the same number of units as in the original test. ·        If no evidence is of microbial growth is found in the repeat test, the product examined complies with the test for sterility. ·        If microbial growth is found in the repeat test, the product examined does not comply with the test for sterility.

‏اللهم صلي على سيدنا محمد وعلى آل محمد Countlesss salutations For the sacred blood of Sayedna Hussain RA and His Sacred Family💚💚💚💚💚💚

Enjoy weekend do your best,Be happy ,Work smart & leave it your God

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‏تقبل الله منا ومنكم ويصلح الأعمال وأنتم بخير عيدكم مبارك Eid Mubarak to all my connections with the warmth of Sunnah Of Prophet Ibrahim in the deepest love for the Almighty lord with ultimate surrender on his order

𝗖𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 𝗮𝗻𝗱 𝗶𝘁'𝘀 𝗰𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻- 𝗽𝗮𝗿𝘁 𝟮 👉Under the GMP requirements, the manufacturing of sterile medicinal products can be distinguished into 4 grades: Grade A, B, C & D. 👉Examples of grades for aseptic preparation and processing operations ➡️𝗚𝗿𝗮𝗱𝗲 𝗔: 👉Definition:A zone for high-risk operations that need the highest level of environmental control. 👉ISO:ISO Class 5 👉Airflow:Under LAF unidirectional 👉Airvelocity:0.36 – 0.54 m/s at working height 👉Utility:Sinks and drains prohibited in Grade A 👉Particle monitoring frequency:Continuous 👉Limit:Settle plate <01 CFu, Active air sampler :<01CFU, Suface : <01 CFU 👉Cleaning frequency:At rest conditions per day 👉Gowning strategy:Sterilized Primary, Secondary fully polyester gown, goggles, gloves 👉Disinfectant:Sterile fliter prior to use as per in-house DET define validity 👉Handling materials:All materials must be sterile like Articles,process operation materials 👉Personal qualifications:On job oriented training and Skills, Media fill participation ➡️𝗚𝗿𝗮𝗱𝗲 𝗕: 👉Definition:A zone for aseptic preparation, filling, and compounding. 👉ISO:ISO Class 5 at rest and ISO Class 7 in operation. 👉Airflow:Minimized turbulence from critical points 👉Airvelocity:0.45 m/s +/- 20% 👉Utility:As per Grade A 👉Particle monitoring frequency:Continuous 👉Limit:Settleplate <05 CFU Active air sampler<10 CFU, Surface <05 CFU 👉Cleaning frequency: At rest per day 👉Gowning strategy:As per Grade A 👉Handling materials:As per Grade A 👉Personal qualifications:As per Grade A ➡️𝗚𝗿𝗮𝗱𝗲 𝗖: 👉Definition:The Grade C cleanroom spaces are for performing less stringent steps of sterile product manufacturing. 👉ISO:Grade C (at rest and in operation) is ISO 7 and ISO 8, respectively. 👉Airflow: Some turbulence away from critical points 👉Airvelocity:0.45 m/s ± 20% at filter face. 👉Utility:No sinks, closed drains and water supply permitted 👉Particle monitoring frequency: 15 days once 👉Limit:Settle plate <50 CFU, Active air sampler <100 CFU, Surface <25CFU 👉Cleaning frequency:Once in a day 👉Gowning strategy:Low particulates, Cleaned, Sterilization not required 👉Handling materials:Protect environment but determined by process requirements 👉Personal qualifications:As per SOP ➡️𝗚𝗿𝗮𝗱𝗲 𝗗: 👉Definition:Grade D cleanrooms are designated for less critical stages in the manufacturing process. 👉ISO:ISO Class 8 cleanrooms, both at rest and in operation. 👉Airflow:NA 👉Airvelocity:NA 👉Utility:Basic hygiene, All equipment permitted 👉Particle monitoring frequency:15 days once 👉Limit: Settle plate <100 CFU, Active air sampler <200 CFU, Surface < 50 CFU 👉Cleaning frequency:NA 👉Gowning strategy:PPE, Head/foot cover 👉Handling materials:Through MAL as needed. 👉Personal qualifications:SOP ➡️𝗖𝗼𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻: 👉However, in general, some will define these various letter grades as follows: A = excellent. B = good. C = satisfactory. D = less than satisfactory.

𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻, 𝗖𝗹𝗲𝗮𝗻𝗶𝗻𝗴 𝗮𝗻𝗱 𝗨𝘀𝗮𝗴𝗲 𝗼𝗳 𝗡𝗼𝗻 - 𝗩𝗶𝗮𝗯𝗹𝗲 𝗽𝗮𝗿𝘁𝗶𝗰𝗹𝗲 𝗰𝗼𝘂𝗻𝘁𝗲𝗿 👉NVPC stands for Non-Viable Particle Count 👉It refers to the measurement and monitoring of the concentration of non-living or inanimate particles present in the air within a controlled environment. 👉Non-viable particles are monitored using particle counter. 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲 👉A non-viable particle is a particle that does not contain living microorganism but acts as transportation for viable particles. 👉A particle passes through a laser beam, and a photodetector is used to detect the change in the light. 👉 Basically, the particle casts a shadow, and the particle counter uses that shadow to determine the size and number of particles. 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗻𝗴 𝗽𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲 👉Ensure the fully charge of the equipment 👉Carryout to the working place 👉Before operation ,do purge the equipment by Zero filter(Zero Count Filter & Zero Counting-This is a filter that attaches onto the sample inlet of the particle counter and enables the user to determine that the sensor is clean, the number of falsely reported particles using filtered air at the optimum flow rate for a given amount of time.) 👉After completion of Zero filter for 0-1 min, To start the dynamic sampling (1 min) or tatic sampling (10min) on the location( Delay time 15 sec- A delayed start allows any impact or environmental contamination from the operator to be 'cleaned' from the area before the sample is taken) 👉This helps to ensure that the operator setting the samples does not influence the sample result. 👉After sampling to stop automatically and print the data. 👉Check the data within the limits 𝗦𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝗰𝗲 𝗼𝗳 𝟬.𝟱 𝗮𝗻𝗱 𝟱 𝗺𝗶𝗰𝗿𝗼𝗻 👉Most of the commonly found bacteria are in the size range of 0.5 to 5.0 micron so this size range is the main source of contamination. 𝗖𝗮𝗹𝗶𝗯𝗿𝗮𝘁𝗶𝗼𝗻 👉Once in year by approved vendor 𝗖𝗹𝗲𝗮𝗻𝗶𝗻𝗴 👉Clean the Equipment by using 70% IPA (Before cleaning ensure OFF, unplug, close sampling probe) 👉To clean the equipment from Low grade to high grade 𝗦𝗮𝗳𝗲𝘁𝘆 𝗮𝗻𝗱 𝗣𝗿𝗲𝗰𝗮𝘂𝘁𝗶𝗼𝗻𝘀 👉It is an essential in pharmaceutical manufacturing to ensure the control and prevention of airborne contamination. 👉Overall, environmental monitoring for aseptic processes evaluates whether ISO-certified clean environments (such as restricted-access barrier systems (RABS) and isolators used for aseptic processing) are suitable for preventing microbial contamination of medical products during manufacturing, packaging, or testing. Reference:USP<797>