Tajamul Manzoor’s Post

𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻, 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 static 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>

𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻, 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 static 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>

Usage of Non Viable particle couunter instrument

𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻, 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 a particle counter. 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲 👉A non-viable particle is a particle that does not contain living microorganisms but acts as a 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> #CapsuleFillingMachine #PharmaceuticalIndustry #HealthcareProducts #Automation #QualityControl #GMP #Productivity #Innovation #Manufacturing #PackagingTechnology #DrugDevelopment #RegulatoryCompliance #PrecisionMedicine #SupplyChainManagement #Biotechnology #DrugSafety #ClinicalTrials #Nutraceuticals #DrugFormulation #FDARegulations #Biopharmaceuticals

Isolator technology: 8.1 The use of isolator technology to minimize human interventions in processing areas may result in a signifi cant decrease in the risk of microbial contamination of aseptically manufactured products from the environment.There are many possible designs of isolators and transfer devices.The isolator and the background environment should be designed so that the required air quality for each zone can be realized. Isolators are constructed of various materials more or less prone to puncture and leakage. Transfer devices may vary from single-door to double-door designs to fully-sealed systems incorporating sterilization mechanisms. 8.2 The transfer of materials into and out of the unit is one of the greatest potential sources of contamination. In general the area inside the isolator is the local zone for high-risk manipulations, although it is recognized that unidirectional airfl ow may not exist in the working zone of all isolators and transfer devices. 8.3 The air classifi cation required for the background environment depends on the design of the isolator and its application. It should be controlled, and for aseptic processing it should be at least Grade D. 8.4 Isolators should be introduced only after appropriate validation. Validation should take into account all critical factors of isolator technology, for example, the quality of the air inside and outside (background) the isolator, sanitization of the isolator, the transfer process and isolator integrity. 8.5 Monitoring should be done routinely and should include frequent leak testing of the isolator and the glove/sleeve system. Reference:WHO Guidlines for GMP of sterile area TRS-961, Annex-6.

📚 𝙎𝙩𝙚𝙧𝙞𝙡𝙚 𝙁𝙞𝙡𝙡𝙞𝙣𝙜 𝙄𝙨𝙤𝙡𝙖𝙩𝙤𝙧𝙨 - 𝙊𝙥𝙚𝙧𝙖𝙩𝙞𝙤𝙣 𝙖𝙣𝙙 𝙌𝙪𝙖𝙡𝙞𝙛𝙞𝙘𝙖𝙩𝙞𝙤𝙣 𝘾𝙖𝙨𝙚 𝙎𝙩𝙪𝙙𝙮 1️⃣ 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝗰𝗲 𝗼𝗳 𝗦𝘁𝗲𝗿𝗶𝗹𝗲 𝗙𝗶𝗹𝗹𝗶𝗻𝗴 𝗜𝘀𝗼𝗹𝗮𝘁𝗼𝗿𝘀: ▶ They ensure the uninterrupted supply of quality products and operator #protection for hazardous drug products. ▶ Isolators create a clean room environment, enhancing #sterility assurance. 2️⃣ 𝗗𝗲𝘀𝗶𝗴𝗻 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀: ▶ Aseptic processing includes entry of sterile stoppers and seals, #pressurization scheme, and sanitization methods like manual and VHP. ▶ Hazardous drug product isolators require #decontamination and proper removal of contaminated waste. 3️⃣ 𝗘𝗿𝗴𝗼𝗻𝗼𝗺𝗶𝗰𝘀: ▶ Adequate mock-up of fill line equipment and #identification of operational trouble spots (e.g., stopper, seal, and vial transport) are essential. ▶ Access to transport parts and environmental monitoring plates should be carefully considered. 4️⃣ 𝗘𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗣𝗿𝗼𝗴𝗿𝗮𝗺: ▶ Continuous monitoring of particulate, active viable air, and passive viable air is crucial throughout the #filling process. ▶ End-of-batch monitoring and surface monitoring using RODACs and #swabs are performed. 5️⃣ 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗰𝗲𝘀𝘀: ▶ Installation & Operational Qualification, airflow testing, VHP cycle development, and performance qualification are conducted. ▶ Preliminary lethality studies help identify challenging and easy-to-decontaminate areas. 👉 Follow Pharma Broadcast and Henry for more updates _________________________________________________ 🌟 𝗣𝗿𝗼𝗽𝗲𝗿 𝗱𝗲𝘀𝗶𝗴𝗻, 𝗾𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻, 𝗮𝗻𝗱 𝗲𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹 𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗮𝗿𝗲 𝗸𝗲𝘆 𝘁𝗼 𝗺𝗮𝗶𝗻𝘁𝗮𝗶𝗻𝗶𝗻𝗴 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗼𝗽𝗲𝗿𝗮𝘁𝗼𝗿 𝘀𝗮𝗳𝗲𝘁𝘆. #SterileFillingIsolators #Pharmaceuticals #QualityAssurance #DrugProduction #CleanRoom

☆ USP <117> 《LABORATORY LAYOUT AND OPERATIONS》 1- Laboratory layout and design should carefully consider the requirements of good microbiological practices and laboratory safety. 2- It is essential that cross-contamination of microbial cultures be minimized to the greatest extent possible, and it is also important that microbiological samples be handled in an environment that makes contamination highly unlikely. 3- In general, a laboratory should be divided into clean or aseptic areas and live culture areas. Areas in which environmental or sterile product samples are handled and incubated should be maintained completely free of live cultures, if possible. 4- If complete separation of live and clean culture zones cannot be accomplished, then other barriers and aseptic practices should be employed to reduce the likelihood of accidental contamination. 5- These barriers include protective clothing sanitization and disinfection procedures, and biological safety cabinets designated for clean or aseptic operations only. 6- Procedures for handling spills or mishaps with live cultures should be in place, and all relevant technical personnel should be trained regarding these methods. 7- Some samples will demonstrate microbial growth and require further laboratory analysis to identify the contaminants. When growth is detected, the sample should be taken from the clean section of the laboratory to the live culture section without undue delay. 8- Subculturing, staining, microbial identification, or other investigational operations should be undertaken in the live culture section of the laboratory. 9- If possible, any sample found to contain growing colonies should not be opened in the clean zone of the laboratory. Careful segregation of contaminated samples and materials will reduce false-positive results.

𝗔𝗻 𝗼𝘃𝗲𝗿𝘃𝗶𝗲𝘄 𝗼𝗳 𝗜𝘀𝗼𝗹𝗮𝘁𝗼𝗿 𝗶𝗻 𝗖𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 - 𝗣𝗮𝗿𝘁 𝟭 👉An isolator is a type of clean air device that creates an almost complete separation between a product and its production equipment, technical personnel, and surrounding work environment. 👉Isolators are units that are completely isolated from the outside environment and are often considered the best solution for a high degree of sterility. 👉Since isolators require extensive decontamination actions when changing products, they are best suited for manufacturing individual products in large quantities. 👉In the world of GMP pharmaceutical manufacturing facilities, isolators enable sterile, contamination-free environments for sensitive processes such as manufacturing and research of GMP products and processes. 👉They are also used to aid in safe handling of hazardous materials, toxins, and pathogens. 👉An isolator is an item of equipment which uses a leak-tight physical barrier, as described in the ISO standard 10648-2, to bring about a separation. 👉Depending on use, personnel/the environment or the product must be protected. 👉Isolators are therefore either at positive or negative pressure. 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲 : 👉It should be noted that enclosed isolators are always positively pressurized units with High-Efficiency Particulate Air (HEPA) filters that supply ISO 5 airflow to the interior in a unidirectional manner. 👉In most cases, air is recirculated, and cleaning can be automated or manual. 👉An isolator for the pharmaceutical industry also integrates air treatment and filtration systems. 👉They renew the air inside the chamber. Pre-filters at the inlet and filters at the outlet remove particles, microbes or other elements that could break the asepsis with greater efficiency. 𝗟𝗲𝗮𝗸𝗮𝗴𝗲 𝗿𝗮𝘁𝗲 𝗼𝗳 𝗜𝘀𝗼𝗹𝗮𝘁𝗼𝗿: 👉 Isolators with permanent leak-tightness (‘closed’ isolator, with leak-tight transfer systems) 👉Isolators with sequential leak-tightness (‘open’ isolator, involving entrance of components and exit of products) 👉Under positive pressure, it influences the level of operator exposure to the sterilizing agent in the room 👉Under negative pressure have the predominant function of protecting personnel. 👉Leakage rates can affect the quality of bio-decontamination at the site of the leak during the bio-decontamination process. 👉The leak rates generally used for isolator are based on the ISO 10648-2 standard: ≥in the order of 0.5% V/h for a sterility test isolator, an isolator used for the preparation of cytotoxic drugs, a filling line isolator, at a test pressure of generally 1.5 to 3 times the nominal working pressure. 👉The test is carried out at ambient temperature ≥ 2.5 % V/h for a filling line isolator, at test pressure of generally 1.5 to 3 times the nominal working pressure. 👉The use of air treatment equipment and rooms in accordance with need (aseptic or containment)

Qualification for Depyrogenation Tunnel The working principle of depyrogenation tunnel involves the use of high Temperature dry heat to remove pyrogens from glassware, containers used in pharmaceutical manufacturing. ✍️Parts of the depyrogenation tunnel: 1.Loading area 2.Pre-heating zone 3. heating zone 4.Cooling zone 5.Conveyor belt 5.Airflow system 6.Control system: This is programmable logic controller (PLC) that regulates the temperature, conveyor belt speed, and other parameters of the depyrogenation process. 7.Safety features: Interlocks, alarms, and emergency stop buttons are installed to ensure the safety of operators and prevent equipment damage. ✍️Validation of the depyrogenation process: This process involves testing and monitoring the effectiveness of the tunnel in removing or inactivating endotoxins. This includes the use of biological indicators, such as bacterial endotoxin testing, to ensure that the process meets regulatory requirements. Use of high-efficiency particulate air (HEPA) filters: HEPA filters are used in depyrogenation tunnels to remove airborne particles, including endotoxins, from the air. ✍️ Performance Qualification studies shall be carried out to ensure the equipment for proper operation and its ability to sterilize and depyrogenate the washed vials at the set parameters it's includes: ·  Air Velocity measurement. ·  HEPA FILTER Integrity test by PAO Aerosol test. ·  Air flow pattern test. ·  Non-viable airborne particle count test. ·  Heat Distribution studies. ·  Heat Penetration studies. ·  Endotoxin Challenge study. Validation Point Description: 1.Heat Distribution 2.Temperature Uniformity 3.Cycle Time Establishing the appropriate cycle time to achieve the desired level of pyrogen removal or inactivation. 4.Conveyor Belt Speed 5.Biological Indicators Using biological indicators, such as bacterial endotoxin testing, to confirm the effectiveness of the depyrogenation process. How does a depyrogenation tunnel work? A depyrogenation tunnel works by exposing the equipment to high temperatures for a specific period of time, usually above 250°C, to destroy or inactivate pyrogens. What are pyrogens? Pyrogens are substances that can cause fever when introduced into the body. They can be found in various sources such as bacteria, bacterial endotoxins, and other microbial contaminants. What are endotoxins? Endotoxins are a type of pyrogen that are produced by Gram-negative bacteria and can cause fever and other adverse reactions in patients if present in pharmaceutical products. What is the purpose of the cooling zone in a depyrogenation tunnel? The purpose of the cooling zone in a depyrogenation tunnel is to cool down the equipment to a safe temperature before being unloaded. #pharmaceuticalindustry #asepticprocessing

𝑹𝒆𝒅 𝒉𝒐𝒕 𝒔𝒕𝒆𝒓𝒊𝒍𝒊𝒛𝒂𝒕𝒊𝒐𝒏 The procedure of "red hot" the loop refers to the practice of heating an inoculating loop until it glows red-hot in a flame, usually before and after transferring microbial samples. This technique serves several purposes: 1. **Sterilization**: Heating the loop to red-hot temperatures effectively kills any residual microorganisms that may be present on the loop. This ensures that no contaminants are introduced into the culture or onto the media. 2. **Prevention of Cross-Contamination**: By sterilizing the loop before obtaining a new sample or transferring it to a new medium, the risk of transferring unwanted microorganisms from one sample to another is minimized. 3. **Maintaining Aseptic Technique**: It is a critical part of aseptic technique in microbiology to avoid contamination of cultures and experimental results. Proper sterilization of the loop helps ensure the accuracy and reliability of microbiological experiments and cultures.