11306------77
Cellulose Nitrate, 0,45µm, 300mm x 50m
0.45µm nitrocellulose microporous membrane
High protein binding capacity (up 180 µg of IgG per cm²)
Clean, uniform and very open structure
Smooth and defect free application surface
Works with contact or non contact dispensing equipment
Easily sealed and supported into devices
Fast and homogeneous wetting
High intra and inter lot consistency
The UniSart 0.45µm membrane has been designed to show exceptional consistency in IVD tests with the following features:
Manufacturing and lot information
UniSart cellulose nitrate membranes are formed using an air casting process, where solvents are evaporating from a mix of different cellulose nitrate polymers and additives to eventually form the unique microporous structure needed for LF strip. Test performance is strongly dependent on internal membrane structure and surface quality. Our specifically designed casting machines together with a patented surface finishing process allow us to manufacture reproducable membranes with outstanding consistency and performance.
Cellulose nitrates, the base material of all our diagnostic membranes, is hydrophobic by nature. Membranes are impregnated with an anionic surfactant to ensure wettability for line printing and capillary action. The applied surfactant level has been carefully adjusted to common needs within immunochromatographi
c tests.
Lot size is defined by the total membrane produced out of one of our mix tanks. The size of one lot can vary between 500m² - 4000m².
Master roll The evaporation casting process is a continuous process. Samples of the membrane are checked for quality aspects while the manufacturing process is still running. For this reason one lot is composed of a certain number of master rolls, which are produced in sequence as the membrane is wound continuously out of the casting machine. The standard master roll size is 50 – 100 m long and around 1m wide.
Roll slitting The master rolls are slit using a rotary blade slitting equipment in order not to damage edges into smaller width rolls. An interleaving paper is added between the layers to protect the membrane. Custom width can be obtained from 17 mm up to 320 mm. A slit roll may have some splices. The reason for the splices can be membrane rupture or exclusion of surface defects.
Certificate of Quality A certificate of Quality is delivered in each membrane box. On the certificate of all the UniSart membranes you will find the exact mean value of the capillary speed and thickness of the complete batch from which the slit rolls originate. The variance inside this precise lot will also be provided. A label on each membrane slit roll allows precise tracking. (Ask us for a sample certificate)
Quality Assurance
Consistent high quality of Sartorius membranes is assured by following a strict quality assurance system. All raw material types are selected and approved in accordance with current regulations, recommendations, inhouse guidelines and specifications coming from national and international standards as well as from our Research and Development Department. State of the art production practices following applicable cGMP guidelines including encapsulated and controlled production areas and employee hygiene ensure optimal quality of the final product. The release criteria for UniSart CN membranes are:
Capillary speed
Thickness
Surface quality
Tests are performed in and across casting direction of each master roll. Released materials fulfill the specification in each single test result.
Complete Traceability The type and lot numbers are printed on the label of the protective plastic case/bag and on the label inside the membrane roll core. The traceable lot number allows convenient retrieval of all data compiled on the material used, production steps and QC tests.
For example, on the roll label, you will see: Order number: 1UN14AR100025NTB Lot number: 0210 11301 0800863 Master roll: 7 Final roll: 10 Order number: 1UN - membrane for IVD Application 14 - medium type (around 8µm) A - unbacked R - roll 100 - 100m long (+1m/-0) 025 - 25mm wide (+/- 0,5mm) NTB - packaging by box of 5 rolls Lot number 0210 - month and year of final production 11301 - internal number 0800863 - lot number of the membrane batch master roll number 7 - labeled in sequence final roll 10 - Slit rolls are labeled from the first one on the left to the last one on the right side with increasing numbers.
Quality Management System The products are developed, produced and distributed according to our Quality Management System that is certified for compliance with DIN/ISO 9001:2000.
Storage and handling, safety data and shelf life of UniSart membranes
Attention: Cellulose nitrate membranes are highly flammable. Their flashpoint is approx. 180°C. Always keep these membranes separated by the interleaving paper as originally supplied. The unbacked cellulose nitrate material is considered as a dangerous good according to UN3270. (see detailed informations on storage, shelf life and safety datasheet in downloads)
11306------77
Cellulose Nitrate, 0,45µm, 300mm x 50m
- 0.45µm nitrocellulose microporous membrane
- High protein binding capacity (up 180 µg of IgG per cm²)
- Clean, uniform and very open structure
- Smooth and defect free application surface
- Works with contact or non contact dispensing equipment
- Easily sealed and supported into devices
- Fast and homogeneous wetting
- High intra and inter lot consistency
The UniSart 0.45µm membrane has been designed to show exceptional consistency in IVD tests with the following features:
Manufacturing and lot information
UniSart cellulose nitrate membranes are formed using an air casting process, where solvents are evaporating from a mix of different cellulose nitrate polymers and additives to eventually form the unique microporous structure needed for LF strip. Test performance is strongly dependent on internal membrane structure and surface quality. Our specifically designed casting machines together with a patented surface finishing process allow us to manufacture reproducable membranes with outstanding consistency and performance.
Cellulose nitrates, the base material of all our diagnostic membranes, is hydrophobic by nature. Membranes are impregnated with an anionic surfactant to ensure wettability for line printing and capillary action. The applied surfactant level has been carefully adjusted to common needs within immunochromatographic tests.
Lot size is defined by the total membrane produced out of one of our mix tanks. The size of one lot can vary between 500m² - 4000m².
Master roll
The evaporation casting process is a continuous process. Samples of the membrane are checked for quality aspects while the manufacturing process is still running. For this reason one lot is composed of a certain number of master rolls, which are produced in sequence as the membrane is wound continuously out of the casting machine. The standard master roll size is 50 – 100 m long and around 1m wide.
Roll slitting
The master rolls are slit using a rotary blade slitting equipment in order not to damage edges into smaller width rolls. An interleaving paper is added between the layers to protect the membrane. Custom width can be obtained from 17 mm up to 320 mm. A slit roll may have some splices. The reason for the splices can be membrane rupture or exclusion of surface defects.
Certificate of Quality
A certificate of Quality is delivered in each membrane box. On the certificate of all the UniSart membranes you will find the exact mean value of the capillary speed and thickness of the complete batch from which the slit rolls originate. The variance inside this precise lot will also be provided. A label on each membrane slit roll allows precise tracking. (Ask us for a sample certificate)
Quality Assurance
Consistent high quality of Sartorius membranes is assured by following a strict quality assurance system.
All raw material types are selected and approved in accordance with current regulations, recommendations, inhouse guidelines and specifications coming from national and international standards as well as from our Research and Development Department.
State of the art production practices following applicable cGMP guidelines including encapsulated and controlled production areas and employee hygiene ensure optimal quality of the final product.
The release criteria for UniSart CN membranes are:
- Capillary speed
- Thickness
- Surface quality
Tests are performed in and across casting direction of each master roll. Released materials fulfill the specification in each single test result.
Complete Traceability
The type and lot numbers are printed on the label of the protective plastic case/bag and on the label inside the membrane roll core. The traceable lot number allows convenient retrieval of all data compiled on the material used, production steps and QC tests.
For example, on the roll label, you will see:
Order number: 1UN14AR100025NTB
Lot number: 0210 11301 0800863
Master roll: 7
Final roll: 10
Order number:
1UN - membrane for IVD Application
14 - medium type (around 8µm)
A - unbacked
R - roll
100 - 100m long (+1m/-0)
025 - 25mm wide (+/- 0,5mm)
NTB - packaging by box of 5 rolls
Lot number
0210 - month and year of final production
11301 - internal number
0800863 - lot number of the membrane batch
master roll number 7 - labeled in sequence
final roll 10 - Slit rolls are labeled from the first one on the left to the last one on the right side with increasing numbers.
Quality Management System
The products are developed, produced and distributed according to our Quality Management System that is certified for compliance with DIN/ISO 9001:2000.
Storage and handling, safety data and shelf life of UniSart membranes
Attention: Cellulose nitrate membranes are highly flammable. Their flashpoint is approx. 180°C. Always keep these membranes separated by the interleaving paper as originally supplied. The unbacked cellulose nitrate material is considered as a dangerous good according to UN3270. (see detailed informations on storage, shelf life and safety datasheet in downloads)
