INSIGHTS ON REGULATORY COMPLIANCE
-
![Part 1 Outline]( "Validation Of A Sterilization Process: Part 1")
Validation Of A Sterilization Process: Part 1Gain essential insights into sterilization by exploring microbial inactivation kinetics, bacterial spore resistance, and key terminology—critical knowledge for ensuring product safety and compliance.
-
![Part 2 Overview]( "Validation Of A Sterilization Process: Part 2")
Validation Of A Sterilization Process: Part 2Gain essential insights into sterilization processes by exploring the Overkill method—an approach that ensures product safety through rigorous cycle development and validation.
-
![Part 3]( "Validation Of A Sterilization Process: Part 3")
Validation Of A Sterilization Process: Part 3Explore the full scope of sterilization activities and gain key insights into cycle development and validation using BI and BB methods to ensure product sterility and regulatory compliance.
-
![Ethylene Oxide part 2]( "Ethylene Oxide For Industrial Sterilization: Part 2")
Ethylene Oxide For Industrial Sterilization: Part 2Sterilization process development ensures product safety and compliance through optimized cycles. Learn how biological indicators and process challenge devices strengthen your sterilization strategy.
-
Ethylene Oxide For Industrial Sterilization: Part 19/9/2025
Understanding EO sterilization requires careful control of cycle variables and strict safety protocols. Learn how evolving standards and best practices ensure both effective sterilization and compliance.
-
Optimal Microbial Sampling Criteria6/24/2025
Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
-
Responding To Fill-Finish And Automation Scale-Up Challenges5/21/2025
Behind every life-saving cell therapy is a complex manufacturing journey. Examine the critical role of automation in overcoming production challenges and ensuring quality.
-
How Process Intensification Supports A Sustainable Future7/1/2025
Discover how process intensification is revolutionizing bioprocessing by boosting efficiency and reducing waste. Hear from experts on how these innovations are driving a more sustainable future.
-
What Is OPC Counting Efficiency?6/24/2025
Ensure cleanroom air quality with optical particle counters. Explore how OPCs work, their performance metrics, and key considerations for choosing the right one.
REGULATORY COMPLIANCE SOLUTIONS
-
![MinicapProE]( "Remote Cleanroom Microbial Air Sampler (Annex 1-Compliant)")
The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).
-
![GettyImages-1474854914-dashboard-hand-digital]( "Transform GMP Data Into Actionable Intelligence")
Explore a system that delivers real-time, compliance-ready analytics, which empowers teams with self-service dashboards, embedded reporting, and actionable calibration and maintenance data.
-
![GettyImages-1294339649 drug development, cleanroom]( "Reliable. Confident. Environmental Monitoring.")
Optimize cleanroom operations with innovative monitoring systems that provide real-time data, improve investigations, and support regulatory compliance for aseptic environments.
-
![GettyImages-1131583289-scientists-laboratory-monitor-screen-computer]( "Enhanced Intelligent Batch Records")
Aizon Execute V2.1.0 is here — and it’s packed with powerful new capabilities designed to make digital batch execution even more flexible, efficient, and intelligent.
-
![Sterile Environment GettyImages-184694561]( "Low Endotoxin Products For Critical Environments")
Many Contec wipes and mops were developed through customer requests. Explore our wipes and mops along with how we minimize the risk of endotoxin contamination of a pharmaceutical product.
