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Bioburden and Microbial Limit Testing in Pharma

Control costs by reducing retest delays and investigations caused by cross-contamination

Decrease Cross-Contamination in Microbial Testing

Reduce false positives for effective product quality monitoring

With regulations only becoming more stringent and new biologics being discovered regularly, performing bioburden, sterility and microbial limit testing of raw materials, intermediates or finished products is a crucial step in the dynamic work done by pharmaceutical producers every day.  Cross-contamination during testing can result in false positives requiring costly retests and delaying your products from reaching the market.

 

Pall engineers work closely with microbiology quality control (QC) teams in the field to design our membrane filtration products to reduce cross-contamination.  Disposable, ready-to-use fi­ltration systems are ideal for quality control analysis of aqueous‑fluids used in pharmaceutical and biologic production.

 

 

Limit membrane handling with easy-to-clean, contamination-control QC designs

 

Our manifold helps to prevent accidental contamination in many ways:

 

  • Requires no tools or tape to put together 
  • Disassembles easily for thorough cleaning
  • Inlet and outlet can be set-up at either end of the manifold, avoiding the risk of contamination due to reaching over the top of funnels to turn on and off valves
  • And that’s only a small example of all the smart contamination-control design elements

 

Our ST MicroFunnel™ filter funnels and packaging are also designed to limit contamination events with the following benefits:

 

  • Available gamma-irradiated so they are sterile and ready-to-use
  • Double-bagged packaging saves time on entry into cleanrooms, isolators or hoods with only one surface to spray down
  • Sterility of each funnel is maintained until its individual packaging is opened
  • Easy-squeeze removal of the funnel prevents membrane tearing and can reduce awkward hand positions required for twist-remove funnels 
  • MicroFunnel Plus version is designed for hot water collection directly from your water loop, limiting sample transfers that can introduce contamination
  • MicroFunnel Plus with our aseptic port (AP) further limits sample exposure by enabling direct hook-up to your water loop with available tubing sets

 

Pall’s disposable filter funnels come with a choice of membranes:

 

  • Regulatory requirement-compliant GN-6 mixed cellulose ester
  • Exceptional flow rate Supor® polyethersulfone 
  • Metricel® Black polyethersulfone for light colonies tough to see on traditional white membranes
  • All supported with a wide array of self-service quality and regulatory documentation available on our website.

Featured Products

 
Pall Manifold
Laboratory

Pall Manifold

Find out how our easy to clean and easy to assemble manifold design reduces the typical challenges with standard manifolds

MicroFunnel ST Filter Funnels
Laboratory

MicroFunnel ST Filter Funnels

A second layer overpack enables quick entry into cleanrooms and hoods with only one bag to wipe down to help reduce both microscopic and gross particulate contamination

MicroFunnel Plus Filter Funnels
Laboratory

MicroFunnel Plus Filter Funnels

Save time and shelf space with a combined MicroFunnel filter funnel and sample cup in one, including Supor® membrane options compatible with hot water loops up to 90° C 

Pall’s Bioburden/Microbial Limits Testing Workflow

Bioburden and Microbial Limits Testing Featured Videos

 

Pall Manifold

 

See the unique design of the Pall laboratory manifold, including the incredible flexibility of this microbiology QC lab staple to work with any of our filter funnels and enable autoclave of a six-place unit in standard equipment.

MIcroFunnel ST Filter Funnels

 

Watch how dual-layer packaging reduces handling steps and potential contamination.

MIcroFunnel Plus Filter Funnels

 

See the time-savings an all-in-one sample cup and funnel can provide.