Log In
Log InSign up
Registration is for professionals that work with containment and Isolation Technologies and grants full access to our product data sheets and catalogues
Sign up
Validation is an essential part of Good Manufacturing Practice (GMP), ensuring that manufacturers identify, control, and document the critical aspects of their processes and equipment. A structured validation approach supports consistent performance, product quality, and regulatory compliance across pharmaceutical and radiopharmaceutical operations.
Comecer supports these requirements by providing Factory Acceptance Test (FAT) protocol validation for every Hot Cell, Dispensing System, and Isolator. The company also performs Site Acceptance Tests (SAT) and, upon request, supplies Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
These validation activities are developed in accordance with recognized international standards and guidelines.
Defines the classification of air cleanliness and the monitoring of controlled environments. It provides the framework for ensuring that cleanroom conditions meet the required particulate limits and remain stable over time, which is critical for aseptic and radiopharmaceutical processes.
Establishes performance requirements for containment systems, including leak tightness and integrity testing. This standard is particularly relevant for isolators and hot cells, where maintaining containment is essential for both operator safety and product protection.
Provides detailed regulatory guidance for the design, operation, and control of sterile manufacturing environments. It addresses contamination control strategies, environmental monitoring, and validation expectations for aseptic processes and equipment.
Offers industry best practices for the design, qualification, and validation of isolator systems used in pharmaceutical manufacturing and testing. It supports a risk-based approach to ensuring sterility assurance and system reliability.
Together, these protocols form a structured validation framework that supports compliance, operational reliability, and process consistency. By aligning equipment and processes with internationally recognized standards, Comecer enables manufacturers to reduce risk, facilitate regulatory approval, and maintain high levels of safety and product quality throughout the lifecycle of their systems.
Validations & Qualification Download
Log In Lost PasswordNews and invitations to events and fairs directly in your mailbox
Subscribe
Technical
Statistical
Targeting
