Eagle’s Post

The Research Pharmacy - Study Product Preparation Compounding Aseptic Isolator. A compounding aseptic isolator is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a HEPA filter. A compounding aseptic isolator is used for non- hazardous study product and has a positive air pressure. #SterilGARD® e3 Compounding Aseptic Containment Isolator A compounding aseptic containment isolator is designed to provide worker protection from exposure to undesirable levels of airborne study drug throughout the compounding and material transfer processes. Air exchange with the surrounding environment should not occur unless the air has first passed through a HEPA filter capable of containing airborne concentrations of the physical size and characteristics of the study product being compounded. Where hazardous drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation. A compounding aseptic containment isolator has negative air pressure. #ChemoSHIELD®

USP general chapters : General chapters may contain descriptions of test and procedures,general chapter information on compendial requirements <1> to <999> : General Tests and assay, mandatory <1000> to <1999> : General I formation, non mandatory Above <2000> : Dietary Requirements. Most common useful USP general chapters : <11> : USP reference standards <85> : Bacterial Endotoxins Test <201> : TLC Identification Test <281> : Residue on ignition <467> : Residual Solvents <621> : Chromatography <731> : Loss on Drying <741> : Melting <643> : TOC <645> : Water conductivity <786> : Particle size distribution by sieve <791>: pH <921> : Water determination <1029> : Good Documentation Guidelines <1058> : Analytical Instrument Qualification <1072> : Disinfectant and antiseptic <1117> : Microbiological best Laboratory practices <1225> : Validation of compendial procedures <1251> : Weighing and Analytical balance <1467> : Residual solvents #learning #UsP #FDA #pharmaceuticalindustry #qaqc #analytical #research #micro #quality

📍Formulation Unit📌🌍💦 1️⃣The preparation of the solution is the active ingredients, auxiliary materials and dissolved ingredients according to the requirements of the work of the bar process to formulate, donut according to the order of the burst of the mixing table, into a batch of prepared solutions, to be filled in the next step. 2️⃣Formulation may include the dissolution of solid active ingredients, or liquid mixing of the cylinder leather. Blanks may include more complex operations, such as emulsification or lipoid formation.Liquid trimming can be done by solubilising with water for injection, or by using an appropriate amount of organic solvent. 3️⃣Prior to preparation, the vessels and packages should be cleaned and aseptically cleaned to minimise microbial contamination (mainly by activated charcoal) from the mixing operation. 4️⃣Formulation of the programme of work of the programme accuracy of preparation(including compositional accuracy,bonito accuracy, pH value, etc.). ::Regularity of work. Uniformity of mixing, etc. 5️⃣The preparation process has measures to prevent contamination and to ensure that the preparation process is in compliance with the regulations.The preparation process has measures to prevent contamination, and the preparation process is sealed and restricted. -—💫. ⭐. 🌟. ✨. ⚡. 🌙—- Build Your Future with EVERHEAL: 📞WhatsApp: +86 18008649427 🖥Website: https://lnkd.in/gsjVzJ_w 📩Email: info@everhealgroup.com 🌏At Everheal, we are committed to delivering top equipment and solutions to meet your pharmaceutical needs. #IVSolution #pharmaceuticalManufacturing #PharmaceuticalEquipment #CustomerCommitment #EVERHEAL #Everheal #Growth #InnovationJourney #EverhealJourney #HealthTechMagic #AutomatedPackaging #SterileProduction #InnovativeTech #Pharmaceuticallndustry #WaterTreatment #PurifiedWater

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. #laboratorylayout #microbiologylab #GMP #GLP #Microbiologist #microbiologistrole #USP #unitedstateofpharmacopia #microbiologistroleinpharma #microbiologybestpractice

Best practices for mobile phase preparation: 1. Use high-purity solvents: Ensure solvents are HPLC-grade or equivalent. 2. Filter the mobile phase: Use a 0.2-0.5 μm filter to remove particulates. 3. Degass the mobile phase: Remove dissolved gases to prevent bubble formation. 4. Prepare fresh mobile phase: Regularly prepare fresh mobile phase to prevent degradation. 5. Use a consistent preparation method: Standardize your preparation procedure. 6. Label and date mobile phase: Clearly identify and date the mobile phase. 7. Store properly: Store mobile phase in a cool, dark place, away from contaminants. 8. Verify pH and conductivity: Ensure the mobile phase meets the required pH and conductivity specifications. 9. Use a mobile phase container: Dedicate a container for mobile phase preparation to prevent contamination. 10. Document preparation: Record the preparation details, including solvents, buffers, and concentrations. Additionally, consider: - Using a mobile phase preparation checklist - Implementing a quality control program for mobile phase preparation - Regularly cleaning and maintaining equipment - Training personnel on proper preparation techniques By following these best practices, you can ensure consistent, high-quality mobile phase preparation, which is critical for reliable chromatographic separations.... #pharmaceutical #pharma #qualitycontrol #QC #chromatography #mobilephase #Hplc

✅Qualification of Depyrogenation Tunnel. The working principle of depyrogenation tunnel involves the use of high Temperature dry heat to sterilize and 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 speed 5.Airflow system 6.Control system: This is a 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. HEPA filters are used in depyrogenation tunnels to remove airborne particles, including endotoxins, from the air. Depyrogenation tunnel Validation and Qualification. 🔹️A 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. To qualify the test the equipment should fulfill the acceptance criteria 🔹️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 con 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 filled. #pharmaceutical #microbiology #sterileprocessing

Flushing the HPLC system with hot water and a specialized cleaning solution, often referred to as a "magic solution," is a crucial maintenance practice in chromatography laboratories. This procedure is essential for ensuring the integrity, reliability, and performance of the HPLC system, and it serves several important purposes. First and foremost, flushing the system with hot water helps to remove accumulated contaminants, residues, and impurities that can adversely affect chromatographic performance. These contaminants may originate from various sources, including samples, solvents, and mobile phases. Over time, they can deposit on system components such as the injector, column, and detector, leading to issues such as baseline noise, peak tailing, and reduced resolution. By thoroughly cleaning these components, flushing with hot water helps to restore optimal system cleanliness and functionality. The addition of a "magic solution" further enhances the cleaning process by targeting stubborn residues and impurities that may be difficult to remove with water alone. This specialized cleaning solution is designed to dissolve and remove organic and inorganic deposits effectively, ensuring a thorough cleaning of the entire HPLC system. By eliminating these residues, the magic solution helps to prevent issues such as carryover, cross-contamination, and column fouling, which can compromise the accuracy and reliability of analytical results. In addition to improving system cleanliness, flushing with hot water and a magic solution also helps to optimize chromatographic performance. By restoring baseline stability, peak symmetry, and resolution, this maintenance procedure ensures that chromatographic analyses are accurate, reproducible, and reliable. It enhances method robustness and compliance with regulatory requirements, which is particularly important in industries such as pharmaceuticals, environmental monitoring, and food safety. Furthermore, regular flushing with hot water and a magic solution can help to minimize the risk of system downtime, instrument malfunctions, and costly repairs. By proactively maintaining the cleanliness and functionality of the HPLC system, laboratories can avoid disruptions to their analytical workflows and ensure continuous operation. This preventive maintenance measure also helps to extend the lifespan of critical system components, including pumps, injectors, detectors, and columns, thereby preserving the long-term performance and reliability of the HPLC system. #MethodDevelopment #Chromatography #AnalyticalScience #ADL #QC #Column #Chemistry #pharmaceutical #science #chemistry

water sampling procedure

Importance of Pipette Precision in Analytical and Microbiological Laboratories 🔹 In analytical laboratories, pipette precision and accuracy are crucial for highly sensitive analyses where small errors can impact results significantly. 🔹 In microbiological laboratories, while precision is important, the margin of error may be slightly higher due to larger sample volumes in some assays. 🔹 Both types of laboratories require pipettes with high precision and accuracy, tailored to the specific needs of the analyses being conducted. 🔹 Regular calibration and maintenance of pipettes are essential to ensure reliable and accurate results in both analytical and microbiological settings. #LaboratoryScience #PrecisionPipetting #AnalyticalLab #MicrobiologyLab #QualityControl #Quality 🔬🧪🔍

Sample Handling in Microbiology Lab: . Viable microorganisms in most microbiology samples, particularly water, EM and bioburden samples, are sensitive to handling and storage conditions. Critical parameters in these conditions include product composition, container composition, time of storage, and temperature of storage. Therfore, it is important to minimize the amount of time between the sampling event and the initiation of testing and to control, as much as possible, the conditions of storage. All microbiological samples should be taken using aseptic techniques, including those taken in support of non-sterile products. If possible, all microbiological samples should be taken under full aseptic conditions in specialized sampling areas. The areas should be as close to the point of use as possible to minimize contamination during transit.