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Basic of GMP

WHO guideline for Sampling

Pre-use post sterilization integrity testing (PUPSIT) Definition Pre-use post-sterilization integrity testing (PUPSIT) is a process used to verify the integrity of a sterilized filter before it is used in a critical process. This testing is conducted after sterilization to confirm that the filter has not been damaged or compromised during the sterilization process. PUPSIT is an important step in ensuring the sterility of the final product and is commonly used in the pharmaceutical, biotech, and medical device industries. PUPSIT process in detail Membrane filters have been used in bioprocessing for many years. Any undetected flaws in the filter membrane could lead to malfunction due to clogging or cross contamination due to insufficient filtration during batch processing. Due to the nature of the membrane, a non-destructive integrity test is necessary so as not to strain the filter prematurely. The PUPSIT procedure is such a non-destructive testing method: By using PUPSIT for integrity testing, manufacturers can ensure and confirm that the filter is compliant, as well as properly installed and intact during filtration. They have the choice of 3 major PUPSIT testing methods, with the so-called Bubble Point Test being the most widely used non-destructive integrity test. It uses water for injection (or WFI in short) that is compliant with ISO standards to moisten the filter. All three different PUPSIT tests can be applied to both filtering options - either using stainless steel filter housings or single-use systems.

5 types of antibodies, each with a different function There are 5 types of heavy chain constant regions in antibodies (immunoglobulin) and according to these types, they are classified into IgG, IgM, IgA, IgD, and IgE. They are distributed and function differently in the body.

Regarding Energy Recovery Unit (ERU) The ERU basically aims to recover part of the energy you would have lost with the Exhaust Air by making a heat exchange with the Fresh Air that will enter the building before it enters the Cooling coil. Let us explain the steps in a simple way: - Exhaust Air: You have places in the building, such as bathrooms, for example, whose temperature is usually slightly higher (it can reach 33 or 35 degrees Celsius). Instead of this air coming out without benefiting from it, we collect it and use it in the heat exchange process. - When you collect (Exhaust Air), it enters the (ERU) unit to make a heat exchange with (Fresh Air) that comes from Libra (its temperature can be, for example, 45 degrees Celsius). - Heat Exchanging: In the ERU unit, the air temperature that comes out of the building (which is 33 or 35 degrees) is transferred to the fresh air. I mean, instead of fresh air entering the Cooling coil at a temperature of 45 degrees, its temperature drops to 38 or 40 degrees. - In short, instead of wasting the energy in Exhaust Air, you use it to reduce the heat of Fresh Air, which helps you save a lot of cooling energy, because the incoming air has become colder, so the air that cools the air does not need to work at high capacity.

GMP - Good Manufacturing Practice Inspections. GMP is a critical part of ensuring that products, particularly in the pharmaceutical, food, and cosmetic industries, are consistently produced and controlled according to quality standards. These inspections are designed to verify that manufacturers are following the guidelines and regulations set by authorities to minimize the risks involved in production. Key Aspects of a GMP Inspection Facility Inspection The inspection ensures that the facility is CLEAN and SANITIZED to prevent contamination. The LAYOUT should minimize the risk of errors and cross-contamination, with separate areas for different operations. Equipment and Maintenance All equipment must be calibrated and maintained regularly to ensure accuracy and reliability. There should be a schedule for PREVENTIVE MAINTENANCE to avoid breakdowns and ensure consistent operation. Raw Materials Raw materials should be tested and verified for quality before use. Proper STORAGE CONDITIONS (temperature, humidity) must be maintained to prevent degradation. Production Processes Clear and detailed SOPs (Standard Operating Procedures) must be followed for each step of the production process. Continuous monitoring during production to ensure compliance with the specifications. Personnel Personnel must be trained in GMP and specific job functions. Employees should follow strict HYGIENE PRACTICES to avoid contamination. Documentation Accurate and comprehensive records must be maintained for all aspects of production. There should be traceability for all materials and processes to track the history of each batch. Quality Control and Assurance Finished products should undergo rigorous TESTING to ensure they meet the required standards. Any DEVIATIONS from the standard process must be documented and investigated. Complaints and Recalls A system should be in place for handling and investigating complaints. Clear procedures for recalling defective products must be established. Validation and Qualification Ensures that the production process consistently produces products meeting quality standards. Ensures that all EQUIPMENT operates correctly and produces reliable results. #QUALITY #GMP #GOOD_MANUFACTURING_PRACTICE #EQUIPMENT #MAINTENANCE #INSPECTION

Isolator vs clean room Isolators vs. Clean Rooms: Which is Better for Pharmaceutical Manufacturing? 🤔🤔🤔 In the world of pharmaceutical manufacturing, the environment in which drugs and vaccines are produced is crucial for ensuring quality and purity. Among the available options, isolators and clean rooms stand out as two primary methods for maintaining a contamination-free environment. But which one is better for pharmaceutical manufacturing? Let’s explore each option. 1. What Are Isolators? Isolators are closed units used to protect products from external contamination during manufacturing and filling processes. These units provide strict control over internal conditions, significantly reducing the likelihood of exposure to environmental factors such as dust and microbes. 2. What Are Clean Rooms? Clean rooms are specially designed environments aimed at minimizing airborne contamination from particles and microbes. They rely on complex ventilation systems and air filtration systems to ensure the quality of incoming and outgoing air. Clean rooms are utilized in various industries, including pharmaceuticals. 3. Advantages and Disadvantages A. Isolators: - Advantages: - Effective protection against contamination. - Reduce the need for large clean rooms. - Flexible usage, as they can be employed in various locations. - Disadvantages: - High initial costs. - May require specialized skills for operation and maintenance. B. Clean Rooms: - Advantages: - Provide a highly controlled environment. - Effective in reducing airborne particles and microbes. - Suitable for large-scale production processes. - Disadvantages: - High operational and maintenance costs. - Require significant space and complex planning. 4. Practical Applications In pharmaceutical manufacturing, the choice between isolators and clean rooms depends on the type of product and quality requirements. For instance, in vaccine production, isolators may be more effective in protecting doses from contamination, while clean rooms may be essential for packaging processes. There is no one-size-fits-all solution when it comes to isolators versus clean rooms in pharmaceutical manufacturing. The choice hinges on a variety of factors, including product type, production scale, and quality requirements. Companies must carefully assess their needs to select the best solution to ensure the safety and quality of their products. #PharmaceuticalManufacturing #IsolatorsVsCleanRooms #QualityControl #InnovationInPharma #Vaccines #PharmaceuticalIndustry #Vials #VaccineProduction #Sterilization #CleanroomTechnology #IsolatorTechnology #QualityAssurance #PharmaInnovation #Sterility #ManufacturingExcellence #Biopharmaceuticals #DrugSafety #HealthcareInnovation #ProcessDevelopment #GMP #RegulatoryCompliance #PharmaTrends #ContaminationPrevention

0.22 um filter details 💡 **Understanding the Role of 0.22-Micron Filters in Pharmaceuticals** 💡 In pharmaceutical manufacturing, maintaining product sterility is critical. One essential tool for achieving this is the **0.22-micron filter**. Here's why it's vital: 🔬 **How It Works**:   These filters are designed to capture and remove bacteria, ensuring a sterile solution by filtering out microorganisms larger than 0.22 microns. They work through **membrane filtration**, where liquids pass through a porous barrier that traps contaminants, while allowing the sterile fluid to flow through. ⚖️ **Benefits**:   - **Sterility Assurance**: Effective bacterial removal. - **High Filtration Efficiency**: Ideal for biological and injectable products. - **Versatility**: Suitable for liquids, gases, and air filtration.    📌 **Key Uses**:   - **Final filtration** in aseptic processing. - **Sterilizing liquid drugs** and biologicals. - Ensuring **cleanroom air quality** in sterile environments. 🔍 **Selection Guide & Considerations**:   When selecting a 0.22-micron filter, consider: 1. **Material compatibility**: Ensure the filter material (e.g., PVDF, PES) is compatible with the solution. 2. **Flow rate**: Higher flow rates may be required for large-volume applications. 3. **Pore integrity**: Regular integrity testing is essential for validation. 4. **Regulatory compliance**: Ensure it meets FDA, EU, and USP standards. For sterile and contamination-free products, selecting the right 0.22-micron filter is essential!

Types of sterilization .. sterilization can be defined as the complete removal of all forms of microorganisms, both vegetative and spore forms, from a surface or an object. Sterilization is carried out by various physical and chemical methods such that it eliminates around 6 log reduction CFU. Physical Methods of Sterilization: 1- Heat Sterilization Heat sterilization is the most effective method of sterilization, where the elimination of microbes is achieved by the destruction of cell constituents and enzymes. It is done by two methods: a. Moist Heat Sterilization: It is one of the best methods of sterilization. Moist heat sterilization is done with the help of an instrument called an autoclave. An autoclave works on the principle of producing steam under pressure. Thus moist heat sterilization is also known as steam sterilization. The water is boiled in an autoclave at 121℃ at a pressure of 15 psi. This leads to coagulation of proteins in the microorganism, and they are effectively killed. b. Dry Heat Sterilization: This method is used on objects that are sensitive to moisture. Moisture-free heat or dry heat is applied on the surface or objects such that there is denaturation and lysis of proteins which leads to oxidative damage, and ultimately the microbial cell dies out or may even burn. Some methods of dry heat sterilization include incinerators, hot air ovens and flaming techniques. 2- Filtration This is a mechanical method of sterilization in microbiology. This method uses membranous filters with small pores to filter out the liquid so that all the bigger particles and microbes cannot pass through. The three steps of filtration are sieving, adsorption and trapping. 3- Irradiation Irradiation is the process of exposing surfaces or objects to different kinds of radiation for sterilization. _________________________________________ Chemical Methods of Sterilization: Chemical methods of sterilization are used in microbiology for biological specimens and plastic equipment. In this method, several chemicals work as bactericidal agents. They can be of two types: gaseous or liquid. 1- Gaseous Sterilization Gaseous sterilization is the method where the object is exposed to gas in a closed, heated and pressurised chamber. The gaseous chemical agents used for sterilization include ethylene oxide, formaldehyde, nitrogen dioxide and ozone. 2- Liquid Sterilization Liquid sterilization is the process of immersing the object in a liquid such that it kills all the viable microorganisms and their spores. This method is less effective than gaseous sterilization and is used to remove low levels of contamination. Common liquid chemical agents that are used for sterilization include hydrogen peroxide, glutaraldehyde and hypochlorite solution. #microbiology #Sterilization #pharmaceutical #sterile #decontamination #GLP #disinfectant #USP #guidelines #sporicidal #disinfectant #SOP

Psychrometric Charts in HVAC Design A psychrometric chart is a graphical representation of the thermodynamic properties of air, providing a comprehensive understanding of the relationships between temperature, humidity, and air quality. In HVAC design, psychrometric charts are an essential tool for optimizing system performance, energy efficiency, and indoor air quality. What is a Psychrometric Chart? A psychrometric chart plots the following parameters: - Dry-bulb temperature (DBT) - Wet-bulb temperature (WBT) - Dew-point temperature (DPT) - Relative humidity (RH) - Humidity ratio (HR) - Enthalpy (h) Key Formulae: - Humidity Ratio (HR): HR = 0.622 x Pw / (P - Pw) - Relative Humidity (RH): RH = Pw / Ps x 100% - Enthalpy (h): h = Cp x DBT + HR x Hv - Sensible Cooling Load (Qs): Qs = 1.2 x CFM x ΔDBT - Latent Cooling Load (Ql): Ql = 0.68 x CFM x ΔHR Standards for HVAC: - ASHRAE 1.5: Climatic Data for Building Design Standards - ASHRAE 55: Thermal Environmental Conditions for Human Occupancy - ASHRAE 62.1: Ventilation for Acceptable Indoor Air Quality Applications of Psychrometric Charts: - Determining the state of the air - Calculating the amount of moisture in the air - Evaluating the effectiveness of cooling and heating systems - Optimizing system design for energy efficiency By understanding psychrometric charts and applying these formulae, HVAC designers can create comfortable and sustainable indoor environments that meet industry standards. #PsychrometricChart #HVACDesign #ASHRAE #IndoorAirQuality #EnergyEfficiency #Sustainability #HVACStandards #BuildingDesign #ThermalComfort #Ventilation #AirQuality