Your one-stop-shop for everything Annex 1

You asked, and we listened. Our Technology and Market Development team polled our QC pharmaceutical customers inquiring how we can best synthesize the new EU GMP Annex 1 regulatory requirements. In response, our team curated the below resources which our customers found to be most effective.

Scientist detecting a contamination, and mitigating its impact by identifying it, quickly and effectively
celsis advance II in a qc microlabatory

On-demand Video: Annex 1 Revisions: Improving Biofilm Detection in WFI Systems Using Rapid LAL Methods
Are your water systems ready for Annex 1? The new revisions on contamination control strategy requirements state water for injection (WFI) systems are a critical utility for manufacturing sterile pharmaceutical products. Explore the enhanced requirements within the Annex 1 revision related to WFI as a critical excipient.

celsis advance II in a qc microlabatory

On-demand Video: Effective Contamination Control Strategy Implementation & Microbial ID
To ensure compliance for your existing and future contamination control strategies, we’ve designed a complimentary three-part virtual workshop presented by Ziva Abraham, President and CEO of Microrite, and Christian Scheuermann, Global Technical Services Manager at Charles River Laboratories.

celsis advance II in a qc microlabatory

On-demand Video: CCS Blind Spots: An Exclusive Look at Contamination Investigations
Ongoing product recalls and continuous regulatory updates (such as EU GMP Annex 1) make it increasingly difficult to identify contamination point of entry, whether it be in the cleanroom, or your product. Examine case studies that teach you how to understand ingress, transport, and proliferation and explore solutions on how to prevent recurring contaminations.

celsis advance II in a qc microlabatory

Guide: Tracking and Trending Microbial ID Data
Maintaining a constant state of microbial control is crucial for preventing contaminations in manufacturing processes and final product release. This guide explores comprehensive tracking and trending solutions with enhanced microbial environmental monitoring and data management capabilities.

celsis advance II in a qc microlabatory

On-demand Video: Tracking and Trending Made Easy
Learn how to leverage tracking and trending features to help you minimize contamination risk, maximize control over your environmental monitoring, and make data-driven decisions.

 

celsis advance II in a qc microlabatory

On-demand Video: Best Practices for Environmental Monitoring and Risk Management
Environmental monitoring programs are designed to provide insights for contamination risk management. Learn key points to consider prior to the initiation of an EM program that will help minimize risk and improve understanding of potential sources of contamination in your facility.

celsis advance II in a qc microlabatory

On-demand Video: AstraZeneca’s Lessons Learned and Benefits Gained from the Global Implementation of an Automated Endotoxin Testing Solution
Automation through robotics represents a new paradigm for bacterial endotoxin testing, streamlining QC processes, and providing widespread operational benefits across organizations. Learn about the change management approach for a global platform technology, technical implementation challenges and how they were overcome, and harmonization of business processes and best practices within a global company.

celsis advance II in a qc microlabatory

Brochure: Interactive Endosafe Cartridge Technology Walkthrough
There’s no mistake that the LAL assay is the gold standard for endotoxin testing, and while conventional kinetic testing is a tried and trusted method, advances in science have allowed for improvement in how it’s utilized. Discover our revolutionary cartridge technology.

celsis advance II in a qc microlabatory

Brochure: Redefining RMM with Celsis
Choosing a rapid method takes more time, energy, and money than ever before, even before you consider what you’ll need to implement it and ensure it works with your products and methods. So how do you know you’re making the right decision for your products, lab, and ultimately, your company? Review our latest brochure to accelerate your decision-making process.

celsis advance II in a qc microlabatory

Infographic: Quick Facts: Celsis Amplified ATP Bioluminescence Rapid Detection
Just being rapid isn’t enough. Your RMM needs to be the Right Microbial Method.
Learn about all of the advantages of our Celsis systems within this infographic.

celsis advance II in a qc microlabatory

Brochure: How Are You Addressing Risk Management and Data Integrity?
Data drives every decision in the lab, so ensuring it is accurate, relevant, and reliable is critical to support confident decisions related to product quality and safety. This brochure will walk you through our three-part solution for ensuring data integrity.

celsis advance II in a qc microlabatory

On-demand Video: Hard to Kill Bugs: Radiation and Disinfectant Resistance in Microorganisms
Microbiologists in the pharmaceutical and medical device industries are aware of microbe resistance to antibiotics in clinical settings and how to address them accordingly. But are they thoroughly and effectively investigating extremophiles living in habitats that would be inhospitable for humans, and the risk they pose to the sterilization process? This three-part video series explores how species acquire resistance and how to respond effectively.

The Micro Newsletter

Get the latest information on trends, innovations, and what’s around the corner for all your laboratory’s needs. Receive exclusive access to limited time resources and live events designed to improve the operational efficiency of your manufacturing environment.

Sign Up Now