Millipak

The Millipak are 0.22 µm membrane filters designed as a safe and efficient barrier against particulates and bacteria.

The Millipak devices use the unique, clean stacked disc design that eliminates the risks of particulate-producing woven downstream support found in many pleated membrane capsules.

The Millipak stacked disc concept offers several benefits

• Adequate support of the flat 0.22 µm membrane, which is supported by a rigid plastic disc with channels to ensure at the same time a high water flow and a resistance to pressure variations without risk of membrane rupture.
  
• Membrane heat sealing on the support that eliminates risks of contamination that may occur when the membrane is bound by solvent.
  
• High surface in a small volume, with a minimum “dead volume”.

The Millipak filters were originally designed for sterilizing filtration of pharmaceutical products and culture media.

The 0.22 µm filtration membranes used in the Millipak have been validated for bacteria removal following the HIMA rules, using a challenge with Pseudomonas Diminuta at 107 organisms / cm² of membrane. The bacteria retention efficiency has been correlated during validation studies with the non destructive bubble point and air diffusion tests in order to allow the verification of bacteria retention for each device at the end of the manufacturing process.

Millipak Operation

These filters are used in laboratory water systems since many years to remove particulates and also prevent the intrusion of bacteria from the laboratory air inside the water system.

The filling bell provides protection against airborne bacteria contamination when ultrapure water is delivered; the filling bell and cap limit airborne bacteria intrusion in the water downstream of the 0.22 µm membrane when the system is not used.

Whenever it is important to reduce bacteria contamination of the ultrapure water, it is a good laboratory practice to keep the filling bell with the end cap in place when the system is not used, and to throw away at least 100 mL of water every morning to eliminate the airborne bacteria that might have developed during the night in the water volume downstream of the membrane. The connection of tubing at the outlet of the Millipak should be avoided as numerous experimentations have demonstrated that such tubing leads inevitably to bacteria development and water contamination.

Millipak High Quality End Filters

Millipak end filters have been designed not only for efficient particulate and bacteria retention; they are also tested to ensure that they will not contaminate the processed liquid by extractible or other contaminants.

This is reflected in the Certificate of Quality delivered with every Millipak where the following Quality Assurance parameters are reported

• Good Manufacturing Practices
  
• ISO® 9001 Quality Standard
  
• Non Fiber releasing
  
• Components Materials Toxicity test
  
• Membrane Bacterial Retention
  
• 100% Integrity testing in Manufacturing
  
• USP Bacterial Endotoxin test Integrity test
  
• Hydraulic Stress Test
  
• Flow Rate and Pressure Drop Measure
  
• USP Oxidizable Substances test
  
• Gravimetric Extractible test
  
• Sterility test (for products delivered sterile)