Sartofluor^® MidiCaps 5185358T8--SS--A

Ready to Use Sterile Filter Units

Unique hydrophobic PTFE membrane

Description

Sartofluor® GA MidiCaps 0.1 µm rated are self contained, ready to use, sterile filter units for sterilizing grade filtration in the pharma/biotech industry. Their unique hydrophobic PTFE membrane is ideally suited for particle removal and sterilizing grade filtration of gases and for filtration of highly aggressive liquids like solvents, acids and bases. Applications: Typical applications include sterile venting of: – Fermenters – Vessels – Glass Bottles The hydrophobic PTFE membrane is also suitable for filtration of aggressive liquids like: – Acids|Bases – Solvents. Easy to use: Sartofluor® GA MidiCaps are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility: Sartofluor® GA MidiCaps are available with various filtration areas from 500 cm² | 0.5 ft² up to 0.45 m² | 5 ft² for easy adoption to any filtration process independent from the batch size. Performance: The unique hydrophobic single layer PTFE membrane provides outstanding flow rates for gases and liquids at low differential pressure assuring most economic system design. Cost Saving: The use of the disposable capsule design concept avoids investments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation. Microbiological Retention: Sartofluor® GA MidiCaps 0.1 µm rated are fully validated as sterilizing grade filters according to HIMA and ASTM F-838-05 guidelines. Quality Control: Each individual element is tested for integrity by B.-P. and Diffusion-Test prior to be released assuring absolute reliability. Documentation: Sartofluor® GA MidiCaps are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.

Applications:

Typical applications include sterile venting of: – Fermenters – Vessels – Glass Bottles. The hydrophobic PTFE membrane is also suitable for filtration of aggressive liquids like: – Acids|Bases – Solvents.

Easy to Use:

Sartofluor® GA MidiCaps are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated.

Flexibility:

Sartofluor® GA MidiCaps are available with various filtration areas from 500 cm² | 0.5 ft² up to 0.45 m² | 5 ft² for easy adoption to any filtration process independent from the batch size.

Performance:

The unique hydrophobic single layer PTFE membrane provides outstanding flow rates for gases and liquids at low differential pressure assuring most economic system design.

Cost Saving:

The use of the disposable capsule design concept avoids investments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation.

Microbiological Retention:

Sartofluor® GA MidiCaps 0.1 µm rated are fully validated as sterilizing grade filters according to HIMA and ASTM F-838-05 guidelines.

Quality Control:

Each individual element is tested for integrity by B.-P. and Diffusion-Test prior to be released assuring absolute reliability.

Documentation:

Sartofluor® GA MidiCaps are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.

Product properties

Branch	Pharma / Biotech
Filter type	MidiCap
Type	Sterile filter
Pore size	0,1 µm
Connector Inlet/Outlet	SS (1 1/2 sanitary Tri-Clamp®/ 1 1/2 sanitary Tri-Clamp®/)
Filtration area	0,1 m²

Technical attributes

Support Layers	Polypropylene (PP)
Structural Compounds	Polypropylene (PP)
Outer diameter	77 mm
Overall length	Connector Combinations SS & FF: 0.05 m² \| 0.5 ft²: 115 mm; 0.1m² \| 1 ft²: 148 mm; 0.2 m² \| 2 ft²: 197 mm; 0.45 m² \| 5 ft²: 330 mm
Min. required Bubble Point	1.5 bar \| 22 psi
Max. allowed air diffusion	0.2 m² \| 2 ft²: 5 ml/min at 0.9 bar \| 13 psi at 20 °C
Bacterial Retention	Quantitative Retention of 1 x E7 CFU/cm² Brevundimonas Diminuta ATCC 19146 per ASTM methodology
Bacterial Endotoxins	<0.25 EU/mL as determined by the LAL test
Extractables	Product meets or exceeds the Quality standards set for "Sterile Water for Injection" by the current USP.
Biosafety	All materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI, (Systemic Injection, Intracutaneous and Implantation tests).
Sterilisation	Autoclaving: Min. 25 cycles at max. 134 °C, 2 bar \| 29 psi, 30 min.
Non-Fiber Releasing	This product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72
GMP Compliance	The product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
Max. Differential Pressure	20 °C: 5 bar; 80 °C: 2 bar
Pore size	0,1 µm
Membrane material	Polytetrafluorethylene (PTFE)