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Explore the World of Horizontal Cylindrical Autoclave Sterilizer Manufacturers Dive into the realm of Horizontal Cylindrical Autoclave Sterilizer Manufacturers on our blog, essential for industries like healthcare and pharmaceuticals. Explore their capabilities, innovations, and how to select the perfect supplier! https://lnkd.in/eugCyvkN

Do you know how to pack hydrogel blister burn patches into 4 sides seal pouch? As a leading manufacturer of pharmaceutical hydrogel patch packaging machines for over a decade, we are proud to introduce the BG600 hydrocolloid patch packaging machine, a cutting-edge solution designed to meet the stringent requirements of the pharmaceutical industry. The BG600 is not just a machine; it's a testament to our commitment to innovation, quality, and efficiency. Here are the key advantages that set the BG600 apart: 1. Precision Engineering: The BG600 is meticulously engineered to ensure precise 4-side seal packaging, which is crucial for maintaining the sterility and integrity of hydrocolloid patches. This precision is vital for pharmaceutical products that demand high standards of safety and hygiene. 2. High-Speed Production: With the BG600, manufacturers can achieve high-speed production without compromising on quality. The machine is designed to handle large volumes efficiently, making it an ideal choice for businesses looking to scale up their operations without increasing turnaround times. 3. Versatility and Flexibility: The BG600 is versatile and can be easily adjusted to accommodate a variety of patch sizes and packaging materials. This flexibility allows manufacturers to use the same machine for different products, reducing the need for multiple machines and saving on costs. 4. User-Friendly Interface: The machine features an intuitive, user-friendly interface that simplifies operation and reduces the need for extensive training. This not only enhances productivity but also minimizes the risk of human error, ensuring consistent and reliable packaging outcomes. 5. Quality Assurance: Built with quality in mind, the BG600 includes advanced sensors and quality control mechanisms to detect and reject defective packages. This ensures that only the highest quality products reach the market, reinforcing brand reputation and customer trust. 6. Energy Efficiency: In an era where sustainability is paramount, the BG600 stands out for its energy-efficient design. It consumes less power without compromising on performance, helping manufacturers reduce their carbon footprint and operational costs. 7. Durability and Longevity: Constructed with high-grade materials and components, the BG600 is built to last. Its robust design ensures durability and longevity, making it a sound investment for any pharmaceutical packaging operation. In conclusion, the BG600 hydrocolloid patch packaging machine represents the pinnacle of our expertise in pharmaceutical packaging solutions. Its combination of precision, speed, versatility, user-friendliness, quality assurance, energy efficiency, durability, and compliance with international standards makes it an indispensable asset for any manufacturer in the pharmaceutical industry.

Vacuum Leak Test (VLT), Acceptance Criteria and its Importance in Pharmaceuticals ______________________________ Vacuum leak test is performed to check any leakage in autoclaves. This test is also called chamber integrity test. In VLT, first vacuum is applied inside the chamber and then wait for the vacuum to reach at set vacuum point then hold the vacuum for required time and when hold time completed vacuum breakage occures. After that check the results whether autoclave leakage is within the limits or not. As per HTM 2010 guideline VLT should be performed on weekly basis. But it is good to perform VLT on daily basis becasue this is very critical test which define the integrity of the chamber. If there is any leakage in the autoclave chamber or leakage is exceeding the limits it means there might be chance of entering non sterile air inside the chamber. When vacuum break happens, air enter inside the chamber through the 0.22 micron filter which is located on the unloading side of the autoclaves. There is no chance of contamination because sterile air enters inside the chamber after filtering through 0.22 micron filter. But if air enter inside the chamber from any other connectivity of the chamber other than the filter, non sterile air would enter inside the chamber and it could contaminate the sterilized load. Acceptance criteria for VLT: As per HTM 2010 VLT should be not more than 1.3 mbar per minute. But in printouts of some autocalves the acceptance criteria mentioned is 0.013 bar and not showing whether this vacuum leakage limit is per minute or per 10 minute. That might cause confusion for the operator. To clear this confusion, I am explaining this concept and it would be easy for you to understand. For example: Vacuum at hold time start: X Vacuum at hold time end: Y Actual leakage: X-Y=Z per minute and if we check leakage for 10 minutes then Z X 10 gives you the result for vacuum leakage per 10 minutes. HTM 2010 says that acceptance criteria is NMT 1.3 mbar per minute Some autoclave print outs give the results as 0.013 bar 1 bar = 1000 mbar = 0.001 bar per minute or 0.010 bar per 10 minutes so, 1.3 mbar per minute or 0.0013 bar per minute or 0.013 bar per 10 minutes. It means the acceptance criteria mentioned by some autoclave vendors in their printouts is 0.013 bar per 10 minutes which is having the same meaning of 1.3 mbar per minute as mentioned in HTM 2010 guideline. 🔱👑👑😄⚡

#Depyrogenation #Tunnel #Conveyor ### Steps for Conveyor Speed Qualification 1. **Determine the Required Dwell Time:** - Identify the minimum dwell time necessary to achieve effective depyrogenation. This is usually based on thermal validation studies. - Refer to guidelines like the **USP <1211> Sterilization and Sterility Assurance of Compendial Articles** and **FDA's Guidelines on Sterilization Processes for the Terminal Sterilization of Drugs**. 2. **Select Appropriate Temperature Profiles:** - Verify the temperature profile for the depyrogenation tunnel. Typically, a temperature of 250°C for 30 minutes is used, but this can vary depending on the specific requirements. 3. **Set Conveyor Speed:** - Calculate the conveyor speed based on the length of the hot zone and the required dwell time. - For example, if the hot zone is 3 meters long and the required dwell time is 30 minutes, the conveyor speed would be (3 meters / 30 minutes) or 0.1 meters per minute. 4. **Perform a Trial Run:** - Run the conveyor at the calculated speed and measure the actual dwell time of the containers within the hot zone. - Use thermocouples or other temperature measuring devices to confirm that the containers reach and maintain the necessary temperature for the required time. 5. **Documentation and Validation:** - Document the trial run data, including conveyor speed, dwell time, and temperature profiles. - Compare the measured dwell time and temperatures against the required specifications to ensure compliance. 6. **Routine Monitoring:** - Implement routine monitoring of conveyor speed during regular operations to ensure consistent performance. - Regularly calibrate and maintain the conveyor system to avoid deviations. ### References and Guidelines 1. **USP <1211> Sterilization and Sterility Assurance of Compendial Articles:** - This chapter provides comprehensive guidelines on various sterilization methods, including depyrogenation. 2. **FDA's Guidelines on Sterilization Processes for the Terminal Sterilization of Drugs:** - This document outlines best practices for validating sterilization processes, including thermal depyrogenation. 3. **European Pharmacopoeia (Ph. Eur.):** - The European Pharmacopoeia also provides standards for sterilization and depyrogenation processes. 4. **ISO 20857:2010:** - This international standard specifies requirements for dry heat sterilization and depyrogenation processes. 5. **PDA Technical Report No. 3: Validation of Dry Heat Processes Used for Depyrogenation and Sterilization:** - Published by the Parenteral Drug Association (PDA), this report offers detailed guidance on validating dry heat depyrogenation processes.

If you need robust and reliable fill-finish equipment that causes minimal disruption to your existing footprint, the Hull i-Dositecno LI Versa-Line™ Pharmaceutical Filling equipment is here to help! Accessibility from one side means you can install at the wall for a linear filling and capping system that fits neatly into any space. Versatile – fill liquids or powders into vials, syringes or cartridges Cleanroom ready – engineered from premium stainless steel and fully compliant with cleanroom requirements Fully compliant – 21 CFR Part 11 compliant integrated software and IQ/OQ validation packages available When it comes to pharmaceutical filling equipment, consistency, accuracy, and versality are key. Having a filling machine that easily adapts to your container closure system while limiting the impact on workflow efficiency can help speed your product to market. The Hull i-Dositecno LI Versa-Line is built on Hull's reputation for quality, offering a single solution for all of your aseptic filling and capping needs. The modular design is easily configurable – enabling simple integration with isolators to ensure maximum sterility and operator safety. Application Examples Human Injectable Products Ophthalmic Eye Care Solutions Veterinary Health Products Oral Solutions Diagnostics & Test Kits ATS Scientific Products

#Sterilizationanddepyrogenationtunnel gives safety up to 350°C. Sterility of containers and closures is a basic requirement for filling injectable solutions. https://lnkd.in/d9eYXY4h #healthcare #pharmacology #pharma #pharmacy #pharmacist #pharmaceuticals #pharmd #pharmacists #pharmacylife #pharmacognosy #research #manager #inos #inostechnologies

CONCEPT OF AIR LOCK SYSTEM IN PHARMA INDUSTRY * 👉Airlock system plays an important role in pharmaceutical industries to protect clean rooms from contaminants and to prevent cross-contamination. An airlock is produced by creating differential pressure between two areas and differential pressure is produced by HVAC.According to WHO a differential pressure of 10-15 pascals should be maintained. ✍️Purpose of Airlock: -The main purpose of the airlock system is to prevent cross-contamination. 1.In a sterile area to prevent the entry of less clean air to high clean area and prevent the entry of microbes from the less clean area to the high clean area. 2.In oral solid dosage forms, manufacturing areas prevent the outflow of powders. ✍️Personnel Airlock (PAL) The airlocks which are used for the entry of personnel into the cleanroom is called personnel airlock (PAL). ✍️Material Airlock(MAL) The airlock which is used for transferring of materials is called Material air Lock (MAL). ✍️Design of Air Lock The airlock is a closed room between two cleanrooms of different classes -Air lock is usually with two doors one door open in one clean room like in class C and other door opens in another class area like in class D. ⭐Both doors of airlock should not be opened simultaneously. First of all open one door and enter into airlock from Class D then close that door and open other door to enter into Class C. ⭐Interlocking system should be installed in airlocks to prevent the opening of both door at the same time. ⭐An alarm system should be installed which give an alert if both doors are opened at the same time. The doors of air lock should be opened towards higher pressure side. ✍️Principle of Air Lock As it is a general role that air moves from an area of higher pressure towards the area of lower pressure. ✍️Types Of Air Locks There are three types of an airlock system -Bubble Airlock -Sink Air Lock -Cascade Air Lock 👉Bubble Air Lock In bubble airlock pressure inside the airlock is high or positive and in adjacent sides, the pressure is less or negative. 👉Sink Air Lock In sink airlock, the pressure inside airlock is negative and in adjacent areas pressure is positive so air moves from higher pressure area to lower pressure area mean from adjacent rooms to the airlock. 👉Cascade Airlock In cascade airlock system pressure increases or decreases in ascending or descending order for example from 30 Pa to 20 Pa to 10 Pa or 10 Pa to 20 Pa to 30 Pa. So air moves from higher pressure to lower pressure side and prevent cross-contamination. ✍️Note: -monitoring of air pressure is required in all areas because any drop or increase in the pressure of any area may result in cross-contamination. -For sterile areas inside is maintained at positive pressure, so air moves from the high clean area to outside low clean area.

3P’s #MicroAuger offers fill weight flexibility and the ability to fill a wide variety of devices including reconstitutable injection devices, vials, cartridges, syringes, inhalers and sachets. https://bit.ly/3s7YgI9 #pharmaceutical #pharmaceuticalindustry #pharma #pharmacy #pharmacist #healthcare #medicine #pharmaceuticals #science #pharmacology #pharmaceuticalcompanies #pharmd #pharmaceuticalmanufacturing #pharmacyschool #laboratory #research #pharmacognosy #pharmacistlife #biology #microbiology #biotechnology #inos #inostechnologies

Hi I hope you would love to read this informative and interesting article as cleanrooms are of great importance in hospitals,drug dispensing areas and pharmaceutical industries. https://lnkd.in/g28dcvtS

Embracing Innovation in Pharmaceutical Safety with Gaible's Advanced Cleanroom Coveralls As the pharmaceutical industry continues to evolve, so does the need for state-of-the-art personal protective equipment. Gaible is at the forefront of this innovation with our 3-in-1 cleanroom coverall. #CleanroomCoveralls #PharmaceuticalSafety #PPE #SterileEnvironment #ParticleRetention #QualityMaterials #PharmaceuticalManufacturing #InnovativeDesign #SafetyAndEfficiency #ContaminationControl #PharmaIndustryEvolution #AdvancedPPE #SterilizationResistance #Durability #GaibleTechnology Join us in our commitment to advancing pharmaceutical safety: https://lnkd.in/gbWxUifX