For water and bioburden testing, Membrane filtration is the method of choice and accuracy is crucial to prevent wasting precious time on false positive or false negative results. Merck has taken time to carefully observe the whole membrane filtration workflow, to determine improvement possibilities and develop, hand-in-hand with customers, a solution to simplify and protect the microbial testing procedure. The Milli flex Oasis System, the Company’s most current system has 96 brand new features to increase result reliability and traceability while streamlining the bioburden testing workflow.

• Operator-independent handling steps, Enhanced touch-free membrane transfer with colour-coded components for increased result reliability
• 50 percent faster filtration time Compared with previous product generation

Reduced decontamination and maintenance time for optimised productivity. Two dimensional tags and codes on Primary and secondary packaging, on each funnel and media plate, for traceability and regulation compliance. The Organization’s new system offers an all-in-one Filtration solution with sterilised, ready-to-use filtration units and pharmacopeia-compliant media for comfort and peace of mind for water and bioburden testing. Detecting abnormal tendencies early and adjusting microbial growth Could possibly save money on remediation efforts and protect against product recalls. Bioburden data and trends should be evaluated to determine whether the amounts remain appropriate over time, and periodic spikes in the data must be assessed, even if they stay within limits.

There are multiple examples of case studies that describe the Importance of properly monitoring trends and in-process bioburden data. The following hypothetical case study follows Business 1X as it finds the story behind its bioburden data. Many production facilities obtain an occasional alert level spike. Business 1X was no different. The in-process upstream bioburden data had a tendency of low-level bioburden. On occasion, a spike above the alert level would happen. Dose audits Are done as a check to make certain that the sterilization procedure is still generating adequately sterilized products. All sterility testing is conducted in an ISO Class 5 environment. The microbiology laboratory at Pacific Biolabs is experienced in Preparing and testing a huge array of devices, from small needles to large, complex devices. For large apparatus, Sample Item Portion SIP preparation may be necessary. This includes cutting a device into bits for analysing, or choosing the most suitable elements of a device for testing.