Regulatory Compliance Solutions

  1. Cleanroom Capabilities And Expertise

    Learn how the right partner can ensure that your facilities maintain cGMP-compliance and help establish the correct testing program and parameters based on your needs.

  2. Remote Cleanroom Microbial Air Sampler (Annex 1-Compliant) 12/1/2022

    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).

  3. What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?

    As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.

  4. Pharmaceutical Automation And Information Technology Services 12/21/2020

    As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.

  5. Sterility Testing For Cell Therapy Bioproduction Samples 6/20/2024

    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.

  6. Axon Digidata 1550B Low-Noise Data Acquisition System Plus HumSilencer 6/20/2023

    High-resolution, low-noise digitizer with 50/60 Hz line-frequency noise elimination.

  7. Rapid Sterility Testing: Actionable Results In Less Than 5 Hours 6/20/2024

    Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.

  8. Corrective Action Preventive Action (CAPA) Software For Life Sciences 8/23/2021

    Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

  9. Class 2 Biological Safety Cabinet: Type B2 8/29/2023

    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.

  10. Optima™ XPN Ultracentrifuge 6/16/2023

    1,500 mL max rotor capacity 100,000 max RPM 802,400 x g

    Security and tracking Remote monitoring and control eXPert simulation software.