Supor® EKV Membrane

Superior Performance

Supor EKV filters feature 0.2-micron-rated validated sterilizing-grade membranes. With standard 5- and 10-inch format filters utilizing a laid-over-pleat membrane geometry in capsules and cartridges for high flow rates and throughput performance, their PES membrane ensures very high compatibility over the whole pH range and very low protein binding to ensure the maximum transmission of active ingredients.

 

Benefits

• Very low protein and preservative binding: hydrophilic PES membrane ensures maximum transmission of active ingredients
• Fast and easy scale-up: all process development-scale filter formats are designed to scale directly to larger cGMP filter configurations
• Broad pH compatibility due to PES membrane
• Long life and low filtration costs thanks to a built-in, asymmetric pre-filter layer
• Good wettability for reliable integrity tests

Security of Supply and Reliability of Performance

We manufacture the PES membrane used in our Supor EKV filter capsules and cartridges. All Supor EKV pleated filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

 

Scientifically Validated

With an absolute removal rating of 0.2 µm in liquids, the filters are bacterially challenged using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) liquid challenge at 10⁷ cfu/cm², and extensively scientifically validated and supported with a comprehensive validation guide.

Discs

Format	Effective Filtration Area (EFA) (cm²)	Recommended Batch Volume (L)	Sterilization Options
47 mm Discs	14	0.05 – 2	Autoclave

 

Capsules

Format	Effective Filtration Area (EFA) (cm²)	Recommended Batch Volume (L)	Sterilization Conditions
Mini Kleenpak™ Syringe Filters	2.8	Up to 0.1	Available pre-sterilized, subject to a minimum of 25 kGy of gamma-irradiation
Mini Kleenpak 20 Capsules	20	0.05 – 2	Autoclave: 1 x 60 minutes at 125 ֯C
Mini Kleenpak Capsules	200	2 – 50	Autoclave: 3 x 60 minutes at 140 ֯C Gamma irradiation: maximum of 50 kGy
Kleenpak Capsules	375 – 1500	2 – 160	Autoclave: 5 x 60 minutes at 125 ֯C, slow exhaust Gamma irradiation: maximum of 50 kGy
Kleenpak Nova Capsules	2600 – 6000	100 – 1000	Autoclave: 1 x 60 minutes at 125 ֯C, slow exhaust Gamma irradiation: maximum of 50 kGy

 

Steam-In-Place Capsules

Format	Effective Filtration Area (EFA) (cm²)	Recommended Batch Volume (L)	Sterilization Conditions
Novasip™ Filter Capsules	1500	2 – 160	Autoclave: 5 x 60 minutes at 125 ֯C, slow exhaust Inline: 5 x 60 minutes at 125 ֯C

 

Cartridges

Format	Effective Filtration Area (EFA) (cm²)	Recommended Batch Volume (L)	Sterilization Conditions
Junior Filter Cartridges	1500	30 – 500	Autoclave: 5 x 60 minutes at 125 ֯C, slow exhaust In Situ Steam: 30 x 60 minutes at 125 ֯C
Filter Cartridges	2600 – 6000	100 – 1000	Autoclave: 30 x 60 minutes at 125 ֯C, slow exhaust In Situ Steam: 5 x 60 minutes at 142 ֯C

 

Quality Release Criteria

	47 mm Discs	Mini Kleenpak Syringe Filters	Mini Kleenpak 20 Capsules	Mini Kleenpak Capsules	Kleenpak Capsules	Kleenpak Nova Capsules	Novasip Filter Capsules	Junior Filter Cartridges	Filter Cartridges
Designed, developed, manufactured in accordance with an ISO 9000-certified Quality Management System	●	●	●	●	●	●	●	●	●
Process development	●	●	●	●	●
Manufacturing scale – cGMP			●	●	●	●	●	●	●
Quantitative bubble point of membrane	●	●	●	●	●	●	●	●	●
Integrity testing protocol during manufacture – lot only	N/A	●	●
Integrity testing protocol during manufacture – each filter 100% tested	N/A			●	●	●	●	●	●
Test correlated to microbial retention	●	●	●	●	●	●	●	●	●
Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics	●	●	●	●	●	●	●	●	●
Provided with a Pharmaceutical Certificate of Test		●	●	●	●	●	●	●	●