Critical Environments Solutions
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cGMP Modular Cleanrooms For Radiopharmaceutical Manufacturing
1/26/2024
Discover Germfree’s custom modular radiopharmaceutical manufacturing or compounding cleanroom facility, expertly designed to accommodate a wide range of manufacturing and compounding requirements. This customizable solution caters to the long term capacity needs of radiopharmacies, individual hospitals or entire systems, providing the flexibility and efficiency necessary for today’s demanding healthcare environments.
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FlexiPharm Isolator
6/1/2016
Extract Technology are a leading worldwide supplier of rigid and flexible containment systems for the pharmaceutical healthcare, biotech and chemical markets.
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Pharmaceutical Cleanroom Low Endotoxin Products
11/4/2022
A sterile product is not necessarily endotoxin-free. Contec offers a full line of certified endotoxin control products, including low endotoxin presaturated wipes and dry wipes, both knit and nonwoven, as well as hydrogen peroxide cleaner and IPA, for the most critical applications.
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Cleanrooms And Equipment For mRNA Drug Manufacturing
6/9/2023
Revolutionizing Global mRNA Production: Germfree's Innovative Cleanrooms Drive Manufacturing Success
Cleanroom requirements for mRNA manufacturing encompass stringent particle control, temperature and humidity management, solvent management and robust contamination prevention strategies. Germfree’s advanced cleanroom solutions address these challenges, ensuring seamless equipment integration, process adaptability, and compliance with regulatory standards. Their tailored mobile and modular facilities support the emerging trend for localized vaccine production, empowering biopharmaceutical companies to harness the transformative potential of mRNA technology in a rapidly advancing field, and ultimately contributing to global immunization efforts.
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Vaporized Hydrogen Peroxide Biological Indicators
4/19/2022
APEX Biological Indicator products are designed specifically for the pharmaceutical and medical device industries utilizing H2O2 vapor sterilization. The stainless steel carrier is designed for use with today’s isolator and filling line applications.
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Pre-Designed Pharmaceutical Cleanroom: Express 30K, 10 Months Delivery
9/9/2020
Faciflex Express is a pre-designed cleanroom solution that delivers a commissioned cleanroom in as little as 6 months. Pre-designed standard cleanroom layouts are the next generation for snap together installation of modular panel systems. Faciliflex Express has 3 models 5k, 15k, and 30k representing cleanrooms of approximately 5,000, 15,000, and 30,000 square foot.
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VHP Resistant Remote Particle Counters
3/31/2014
A widely used method to inactivate bio-contamination on surfaces in GMP controlled areas is sporicidal gassing using vaporized hydrogen peroxide (VHP). This decontamination process uses a free radical reaction to kill microorganisms on surfaces.
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AeroTrakā¢+ 7010 Remote Active Air Sampler (AAS)
7/19/2022
TSI AeroTrak+ 7010 Remote Active Air Sampler (AAS) offers aseptic manufacturers confident and reliable microbial monitoring in pharmaceutical manufacturing Grade A and B environments with external vacuum systems.
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Cleaning And Disinfecting For Viruses And Other Pathogens
8/28/2020
Per Center for Disease Control (CDC) guidelines for cleaning and disinfecting viruses and other pathogens, any form of disinfection necessarily follows cleaning. The process of cleaning will remove any residues that might shield any virus or pathogen from the disinfection step that comes next. Disinfection, following thorough cleaning and rinsing, can be done with bleach solutions, 70% alcohol solutions, or other products with EPA-approved emerging viral pathogens claims. As outlined by CDC, bleach solutions should reside on surface for at least one minute and can be made as follows:
- 5 tablespoons (1/3rd cup) bleach per gallon of water, or
- 4 teaspoons bleach per quart of water
An excellent cleaning and wiping solution can be made with 0.5% (0.75- 1.5 oz/gal or 5 mL/L) Alconox® Powdered Precision Cleaner or Liquinox® Critical Cleaning Liquid Detergent, depending on preference for powder or liquid concentrate, respectively. Following which, per the CDC guidelines, wipe with the above bleach solution or other disinfectant solution. Allow wiped-down surfaces to sit for several minutes before rinsing to complete the disinfection.
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Class 2 Biological Safety Cabinet
8/29/2023
The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.