INSIGHTS ON CRITICAL ENVIRONMENTS

  • Viable Monitoring Solutions To Prepare Your Contamination Control Strategy For Annex 1 FAQs

    In our recent webinar many thoughtful questions were asked that concern how compliance with the latest regulation changes can be met, the requirements for passive monitoring, and the industry applications affected. Here we answer questions submitted after the webinar regarding active air and settle plates, rapid micro methods, and specific applications.

  • Choosing The Right CDMO For HPAPI Development, Manufacturing & Packaging

    Pharmaceutical companies recognize the importance of selecting the right partner for the development, manufacturing, packaging, and commercialization of products containing high-potency active pharmaceutical ingredients (HPAPIs). Experts discussed the key considerations and best practices when outsourcing HPAPI development, manufacturing and packaging to a CDMO.

  • Condensation Control In Cleanroom Environments

    Condensation in clean manufacturing facilities can lead to contamination of the environment and compromise the quality of products being produced, so must be avoided. 

  • Utilize Modular Cleanrooms To Reduce Your Risk Of An FDA Form 483 Violation

    Maintaining FDA compliance is essential to your business operations and downtime of any sort could derail your business and potentially harm patients. A cleanroom facility remains safe for your workers – and that the therapeutics they produce remain safe for patients - can ease your compliance concerns.

CRITICAL ENVIRONMENT SOLUTIONS

  • Extract Technology aseptic isolators are designed to allow operators to perform aseptic processes in a sterile environment providing assurance of process integrity.

  • AeroTrak Remote Particle Counters with Integrated Pump are ideal for use in any GMP-controlled area where continuous particulate and environmental monitoring is required. AeroTrak Remote Particle Counter Models 6310, 6510 and the vaporized hydrogen peroxide (VHP)-resistant 6510-VHP have the features needed for seamless integration.

  • Effective and Efficient Vial Washing
    Vial washing cleans the vials of particulate matter and microorganisms; however traditional vial washers have many moving parts, which can themselves generate particulates. SP Hull vial washers have just two moving parts in their washing chamber to ensure highly effective cleaning and their main drive is servo driven. Each vial format has a Human Machine Interface (HMI) selected recipe with specific settings for spray time to help reduce water consumption. Vials are washed without the washing needle entering the vial, thereby eliminating the risk of vials being damaged due to misaligned or bent washing needles.

  • The PharmaGard ES NR800 Compounding Containment Pharmacy Isolator is a Restricted Access Barrier Systems (RABS) that creates negative pressure recirculating ISO Class 5 clean air environment for aseptic compounding of hazardous drugs and minute quantities of chemotherapy drugs to meet USP 800 requirements.

  • Providing a suitable cGMP environment for operators to perform either sampling or dispensing task in a safe and comfortable atmosphere, Extract Technology facilities are high class state of art pieces of equipment. Complete with material and personnel airlocks and a downflow booth, the facility operates with a positive pressure to aid in achieving a clean cGMP environment.

FREE CLEANING VALIDATION E-BOOK

Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.