2024 Updates to CEC’s “Pass-Through Options for Sterile Compounding Facilities” Document
February 2024
We’re thrilled to announce that we’ve updated our document, “Pass-Through Options for Sterile Compounding Facilities.” Our team has worked to enhance and refine our company’s position on pass-through options, ensuring that it reflects the latest insights and advancements in controlled environment certification/testing.
Check out the updated document to stay informed on the most effective strategies for environmental monitoring of sterile compounding facilities.
NSF/ANSI 49 Biosafety: Design, Construction, Performance, and Field Certification March 2023 Update
March 2023
NSF/ANSI 49 Biosafety: Design, Construction, Performance, and Field Certification has been updated as of March 2023. We have summarized the current and all historical changes back to 2008. To see the updated list, click HERE or visit our resources page.
For most of us, these two changes will be the most interesting but be sure to review them all:
Issue statement #161 dealing with Volatile Toxic Chemicals in Class II Type A1 cabinets. This change reverses a change made to the last standard 49 update that made use of Type A1 cabinets for use with volatile toxic chemicals permissible after a chemical risk assessment. Class II Type A1 cabinets are now once again appropriately designated as inappropriate for work with volatile chemicals.
Issue statement #166 will also be of interest. The word dedicated has now been more clearly defined for specific applications. For example, the new language now states that Type B cabinets must be on an exhaust duct and fan dedicated to that individual cabinet and not ganged with other vented devices. There are a total of 10 Issue statements discussed in this update so be sure to review them all.
Updates of USP standards <795> & <797> prompt changes by November 2023 to maintain Compliance
November 2022
The revision and publication of USP standards <795> Pharmaceutical Compounding—Nonsterile Preparations and USP <797> Pharmaceutical Compounding—Sterile Preparations, were published on November 1, 2022. These updates have implemented various changes to maintain best practices and quality and safety standards to help ensure public health. For our affected clients, making the necessary changes and adaptations to fulfill these new requirements can seem arduous. Beginning November 2023, the updates are enforceable. Our team at Controlled Environment Consulting is working diligently to address each client’s individual needs to ensure compliance is met prior to the deadline. Please expect a member of our team to reach out to initiate a conversation and develop an action plan for your specific needs if we have not already done so. Feel free to contact us at info@cenvironment.com for more information. We look forward to speaking with you.
ABOUT US
CONTROLLED ENVIRONMENT INDUSTRY LEADERS
It is our pleasure to announce that we are expanding our business with a new office location.
The new location is 2432 Emrick Blvd Bethlehem, PA 18020.
Please update your records with our new address. We will be moving January 20, 2023 and starting business at our new location on January 23, 2023. Our phone numbers and email addresses will remain the same, as will our website address and social media accounts.
Our new facility offers us the opportunity to better serve our loyal customers and work with our valuable business partners. We look forward to continuing to serve your needs and working with you at our new location.
Feel free to contact us with any questions.
About Us
CEC brings decades of experience in cleanrooms and containment devices. Our network of technical, lab and scientific experts evaluate, analyze and resolve complex problems.
ABOUT US
OUR SERVICES
CERTIFICATION OF CONTROLLED ENVIRONMENTS
We provide life science customers a world-class certification service experience.
FACILITY DESIGN SERVICES
We provide an in-depth analysis of your facility needs, requirements and more.
FACILITY GAP ANALYSIS
We review existing facilities against regulatory requirements such as USP and FDA standards.
TRAINING
We have developed a world-class training for our certification and expert team.
PROJECT MANAGEMENT
Responsible for overseeing new installation, repair or renovation projects.
ADDITIONAL SERVICES
Additional services are available to meet your Engineering and Project Management needs.
ENSURING COMPLIANCE
USP AND FDA COMPLIANCE EXPERTS
With some of the most recognised certification instructors through participation with the Eagleson Institute and Critical Point,LLC – CEC’s experts have been providing controlled environment services training since 1995. We have developed a world-class-in-house training for our certification and expert teams. These training classes will be made available to outside companies