INSIGHTS ON REGULATORY COMPLIANCE
-
![OctoPlus Final Filling Single-Use Set]( "Streamline Production With A Final Filling Single-Use Set")
Streamline Production With A Final Filling Single-Use SetStreamline your production with a Final Filling Single-Use Set that installs in under 10 minutes to eliminate cleaning and sterilization while ensuring Annex 1 compliance and full customization.
-
Understanding Biosafety Levels
Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.
-
![How MSD Stays Inspection Ready]( "How MSD Stays Inspection Ready")
How MSD Stays Inspection ReadyDiscover how MSD ensures continuous inspection readiness with digital validation and ALCOA+ principles to drive compliance, data integrity, and streamlined automation.
-
![West_CZ Insert Needle 115860aw 11569_RGB_2]( "A Practical Packaging Components Checklist For Emerging Biotechs")
A Practical Packaging Components Checklist For Emerging BiotechsA proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
-
Why Cleanroom Wipe Fabrics Matter6/16/2025
Discover the key fabrics used in cleanroom wipes and how they impact performance, as well as explore substrates, manufacturing methods, and essential attributes to help you choose the right wipe.
-
Annex 21 – Are We On Track And Is There An Impact?5/6/2024
What does Annex 21 entail? What makes the process of meeting the requirements so complex and time-consuming? And has Annex 21 inadvertently created additional barriers to supply?
-
A Shift Towards Biofluorescent Particle Counters In Manufacturing5/12/2025
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
-
6 Things To Consider During Visual Inspection Operations7/14/2025
Even with automation, manual visual inspection remains vital in sterile drug manufacturing. Discover six advanced considerations for refining your operations, ensuring compliance, and minimizing costs.
-
From Open Cleanrooms To Closed Systems – What Is Driving The Change?3/14/2025
Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.
REGULATORY COMPLIANCE SOLUTIONS
-
![Class 2 Biological Safety Cabinet Type B2]( "Class 2 Biological Safety Cabinet: Type B2")
The Class 2, Type B2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area is continuously bathed with laminar flow ISO 5/Class 100 HEPA-filtered air while creating a negative pressure airflow into the cabinet to provide user protection.
-
![SteriSEQ™ Rapid Sterility Testing Kit]( "Sterility Testing For Cell Therapy Bioproduction Samples")
This useful tool helps to ensure quality and safety in cell therapy products through the use of a probe-based quantitative PCR (qPCR) assay to detect bacterial and fungal species.
-
![Laptop clinical trials iStock-653839742]( "Pharmaceutical Change Control Software")
Using Document Change Control Software in Regulated Environments
Change is important in any business, but it is especially critical in life science, manufacturing, and other regulated companies, which are required to "control" change as part of compliance. This is why many companies are turning to document change control software to help them address the complexity of change control.
In regulated environments, the term "document change control" may refer to the document management or document control process, or it may to refer to the change control process, which involves rigorous documentation. Either way, most companies need document change control software to manage these processes.
-
![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.
-
![beckman optima xpn]( "Optima™ XPN Ultracentrifuge")
1,500 mL max rotor capacity 100,000 max RPM 802,400 x g
Security and tracking Remote monitoring and control eXPert simulation software.
