Sterility Testing Pump: Sterisart^® Universal | Gen 4

Peristaltic pumps operate using a tubing system that transfers a test sample into a closed container, without coming into direct contact with its components, ensuring the integrity of the sterility testing process. Besides ensuring equal splitting of sample volumes, it offers precise control over flow rates and eliminates the generation of particles and aerosols, safeguarding both the process and the operator.

Several considerations should be taken into account to ensure its suitability

• The design must prioritize contamination control, featuring easy disassembly for thorough cleanability and compatibility with a broad range of sterilants, including Vaporised Hydrogen Peroxide (VHP). 
• The pump should have a low profile since space is of a premium in closed confined spaces such as isolators, laminar flow hoods (LFH) and Biological safety cabinets (BSCs).
• Precision in equal volume splitting and flow rate control is key for achieving accurate and reproducible results. 
• The pump's design should prioritize easy maintenance and robustness to minimize downtime, incorporating fail-safe mechanisms for enhanced reliability. 
• An open design is preferred to ensure operational continuity, aligning with the best practice of validating a second supplier.
• In alignment with the digital era, choose a pump that supports electronic reporting, ensuring future-proof capabilities for evolving process automation needs. This covers features like material data capture, versatile connectivity options, and synchronization capabilities.
• Crucially, verify that the chosen pump complies with relevant regulatory standards for both sterility testing and electronic records maintenance, including adherence to standards like 21 CFR Part 11 and Annex 11.

Compliance with 21 CFR Part 11 and EU Annex 11 is crucial as these regulations set standards for electronic records and signatures in the pharmaceutical and life sciences industries. Adhering to these requirements ensures the integrity, reliability, and security of electronic data, promoting transparency, traceability, and regulatory adherence in critical processes such as sterility testing. 

Non-compliance may lead to regulatory sanctions and organizations can be faced with warning letters from regulatory authorities and potentially a market recall. Ensuring compliance is not only a regulatory requirement but also a strategic approach to maintaining operational excellence and industry credibility.

Best practice recommends that users should utilize manufacturer services, including Instrument Qualification (IQ) and Operational Qualification (OQ), to ensure the proper functioning and compliance with regulatory standards. It is advisable to conduct requalification or include an annex to the IQ/OQ binder when implementing device upgrades.

• Conduct routine visual inspections to detect signs of wear, damage, or contamination. 
• Promptly replace worn parts following recommended intervals for part replacement. 
• Implement a structured cleaning schedule, thoroughly cleaning accessible surfaces using approved sterilants and adhering to decontamination guidelines provided by the isolator manufacturer.
• Periodically verify and recalibrate sensors on the pump (such as the pressure sensor) for accuracy, a service typically offered by the manufacturer. 
• Best practice advocates for a bi-annual service interval, with an annual frequency as the minimum recommendation. 
• Maintain detailed records of qualification, maintenance, calibration, and cleaning activities.
• Adhere strictly to manufacturer guidelines.
• Restricting access to the device and ensure that all personnel operating the pump are adequately trained. 
• Take measures to minimize spillage and exposure to factors that may impact its performance.