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.

• Considerations & Steps For Building A Contamination Control Strategy (CCS)

  9/30/2021

  Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy.

• Improve Bioprocessing Efficiency With A Standardized Automation Platform

  3/9/2021

  Designed specifically for the biomanufacturing industry, Cytiva's Figurate automation is a portfolio of automation platform solutions powered by the reliability of Emerson’s DeltaV.

• AES Clean Technology Career Opportunities

  2/19/2020

  AES Clean Technology provides industry-leading modular clean room facilities with career opportunities in design, manufacturing, installation and sales. Hear how our current employees came on board to AES and what they enjoy about their careers.

• Overcoming Difficult Cleaning Residues In Life Sciences

  5/21/2021

  Introduction and general cleaning concepts including detergent selections and chemistry in Life Sciences, COVID-19, Cannabis Cleaning, RNA and DNA cleaning, and more.

• Replacing Settle Plates With Active Air Sampling

  9/30/2021

  Settle plates are a non-validatable method as it is simply based on the physical principle of the downfall of a particle on a surface. We discuss the using active air sampling versus passive air settle plate monitoring in routine environmental monitoring.