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LK 1476B - 124
LKS 0.2m
LKSX5501EEXX101
AseptiCap KS
Membrane Technologies
DKSX5701EEXX101
LKSX5401EEXX101
LK 7895A - 789
AseptiCap KS
147
LKS 0.2m
DKS 0.2m
mdi DK1146C-
mdi
DKSX5301EDXX101
DK7895C-125
147
DKS 0.2m
DKS 0.2m
mdi DK4555B-
1
10
XX
di
86 m AA
101
m
SX 0.2 - 103
77 0.2 01
7
md 5101JJmXX
47
DK S 51
DK S 6B
D-
DK SX
DK 872
DK
DK
i
DST DKSLKSX1135L 1
AseptiCap KL/KS Datasheet
PES Membrane Devices for Biopharmaceuticals
Asepticap KL/KS 0.2 micron capsule filters use mdi PES Key Features
membrane in Polypropylene housing. No adhesives or glue
are used in the manufacturing process and all bonding is Absolute retention
done by heat welding. 100% integrity tested
T h e p ro d u c t s a re d e e p l y v a l i d a t e d fo r u s e i n Low protein binding
Biopharmaceutical applications and specially recommended
for single use systems. Asepticap KL/KSare manufactured in Very low hold up volume in filters
class 10,000 clean rooms and ISO 9001 certified facilities. High flow rates
Sterile Filtration of
Centrifuge supernatants
DST DKSLKSX1135L 2
Datasheet
Quality Assurance
Total Traceability
Validated for Microbial Retention
AseptiCap KL/KS filters come with completely traceable lot
Integrity test data have been correlated to actual microbial numbers and unique identification number to facilitate easy
retention with B. diminuta (ATCC 19146) as per ASTM F838-05 and fast retrieval of manufacturing and quality control data.
to establish acceptable integrity test values.
These unique lot and identification numbers are laser etched
Samples from each lot are subjected to microbial challenge
on each filter device and also printed on the labels of the box
test before final lot release.
in which individual filter is packed.
100% Integrity Tested
Each AseptiCap KL/KS is tested for integrity to comply with Packaging Integrity
validated acceptable Integrity Test Specifications.
AseptiCap KL/KS filters are fitted with vent caps and are
Flow Rate packed in polyethylene bags to ensure package integrity
during transit as well as to prevent particulate contamination
Each lot is tested for clean water flow rates to ensure that while transferring to clean room assembly or process areas.
flow rates are within the specifications.
DST DKSLKSX1135L 3
Performance Data Datasheet
5% BSA (ml)
streams. 60
40
DST DKSLKSX1135L 4
Datasheet
Performance Data
Extractables
It is useful to evaluate extractables that may be leeched out of the filter and enter the process stream. mdi filters give low
extractables under harsh preconditioning and extraction conditions.
Low extractables mean less addition to impurity profile of the biological product from the filters.
FTIR Analysis of Extractables From AseptiCap KS 1 FTIR Analysis of Extractables From AseptiCap KS 1
Capsule Filter with Water @ 35 C Capsule Filter with 100% Ethanol @ 35 C
Fig 1: FTIR Spectrum of Capsule Filter Extract in Water at 35C for 24 hrs
Fig 3: FTIR Spectrum of Capsule Filter Extract in 100% Ethanol at 35C for 24 hrs
FTIR Analysis of Extractables From AseptiCap KS 1 FTIR Analysis of Extractables From AseptiCap KS 1
Capsule Filter with Water @ 80 C Capsule Filter with 100% Ethanol @ 80 C
Fig 2: FTIR Spectrum of Capsule Filter Extract in Water at 80C for 24 hrs
Fig 4: FTIR Spectrum of Capsule Filter Extract in 100% Ethanol at 80C for 24 hrs
DST DKSLKSX1135L 5
Datasheet
Easy Connect
DK S 0. - 478
1 Sanitary Flange
ED
SX 2m
A
5304
i DDKK0226
to Barb Hose
md
101
6
XX
DK S 0. B- 12
ES
5301 m
SX 2
i DDKK8796
to Sanitary Flange
DST DKSLKSX1135L 6
Linear Upscaling Datasheet
from R&D to Production Process
1
take a keen interest in filter selection at the
10
51 m 7
XX
SX 0.2 55
EE
DK S 15J-
01
DK 84
DK
i
md
formulation development stage itself.
Although preliminary compatibility data
support initial filter selection, for stability
studies detailed filter validations are required
AseptiCap KL/KS AseptiCap KL/KS AseptiCap KL/KS
to provide enough documented evidence to
25mm, 5cm 50mm, 20cm 1, 250cm
justify specific filter use.
1
10
m 7
XX
0.2 - 88
processes.
01 0.2 EE
4
J- m
01
S 5L
03
i DDKKSX57
DK 215
55
10
DK S
53 m 25
DK
XX
i
SX 0.2 - 1
md
ED
DK KS 75L
md
01
D K89
D i
md
mdi offers a wide range of AseptiCap KL/KS
filters to provide linear scale up from lab scale
to production process. While scaling up the
process, the appropriate size filter can be
selected by increasing the effective filtration AseptiCap KL/KS AseptiCap KL/KS AseptiCap KL/KS
area of filter proportionate to the process 2, 500cm 5, 1000cm 8, 2000cm
fluid volumes.
EFA* Hold up
All Materials of construction as well as Filter Devices (Nominal) Volume
manufacturing process are identical for all
filter devices starting from 5 cm to 18000cm AseptiCap KL/KS 25 5cm < 50l
hence process scaling can be facilitated AseptiCap KL/KS50 < 200l
20cm
without triggering additional validation
< 5ml
studies for given process conditions. mdi AseptiCap KL/KS 1 250cm
LK 020.2m XX101
LKSX tiCap KS
- 130
LKS 5401EE
55L
Asep
500cm
of the AseptiCap KL/KS filters there by
AseptiCap KL/KS 5 1000cm < 45ml
reducing the additional validation cost and
time. AseptiCap KL/KS 8 2000cm < 60ml
AseptiCap KS
10, 6000cm
DST DKSLKSX1135L 7
Specifications Datasheet
0.2 m AseptiCap KL/KS
Construction
Membrane 0.2 m Hydrophilic PES
Upstream Membrane
0.8 m, 0.65 m or 0.45 m Hydrophilic PES
(in case of AseptiCap KS)
Plastic parts Polypropylene
Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm
Size
Size 25mm 50mm
SHB I/O 79 mm
Sanitary Flange
Dimensions Inlet I/O 51 mm
(End to End)
Female Luer Lock Inlet/
Male Luer Slip Out let 23 mm
Operational Radius
15 mm 28 mm
(with Vent/ Drain)
Operational
Max. Operating Temperature 55 C 60 C
Assurance
Toxicity Passes Bioreactivity test, In vivo, as per USP <88> for Class VI plastics
Cytotoxicity Passes Biological Reactivity Tests, In vitro, USP <87> for cytotoxicity
Bacterial Retention LRV> 7 for B. diminuta (ATCC 19146) per cm of filter area as per ASTM F 838-05
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a specified
minimal flush
DST DKSLKSX1135L 8
Specifications Datasheet
0.2 m AseptiCap KL/KS
Construction
Membrane 0.2 m Hydrophilic PES
Upstream Membrane
0.8 m, 0.65m or 0.45 m Hydrophilic PES
(in case of AseptiCap KS)
Support Layers Polyester
Plastic parts Polypropylene
Microbial Retention LRV > 7 for Brevundimonas diminuta (ATCC 19146) per cm
Size
Size 1 2 5 8
Effective Filtration Area (Nominal) 250cm 500cm 1000cm 2000 cm
1 Sanitary Flange I/O 91 mm 110 mm 161 mm 211 mm
Hose Barb I/O 90 mm 112 mm 164 mm 215 mm
Dimensions
(End to End) 1 Sanitary Flange Inlet
Single Step Hose 90 mm 111 mm 162 mm 212 mm
Barb Outlet
Sanitary Flange I/O 103 mm 155 mm 205 mm
Operational Radius
30 mm 65 mm 65 mm 65 mm
(with Vent/ Drain)
Vent and Drain 1/4 Hose Barb with Silicone O rings
Operational
Max. Operating Temperature 80 C @ < 30 psi (2 Kg/cm)
Max. Differential Pressure 60 psi (4 Kg/cm) @ 30 C
By Gas Sterilizable by Ethylene Oxide
Sterilization
By Autoclave Autoclavable at 125 C for 30minutes, 25 Cycles. Can not be in-line steam sterilized
Shelf Life 3 Years after EO Sterilization
Assurance
Toxicity Passes Bioreactivity test, In vivo, as per USP <88> for Class VI plastics
Cytotoxicity Passes Biological Reactivity Tests, In vitro, USP <87> for cytotoxicity
Bacterial Retention LRV> 7 for B. diminuta (ATCC 19148) per cm of filter area as per ASTM F 838-05
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush
pH Compatibility Compatible with pH range of 1 - 10
Extractables with WFI Passes test as per USP
Indirect Food Additives Comply with USFDA 21 CFR Part 177.1520
Oxidizable Substances Within limits as specified in USP
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
DST DKSLKSX1135L 9
Specifications Datasheet
0.2 m AseptiCap KL/KS
Construction
Membrane 0.2 m Hydrophilic PES
Upstream Membrane
0.8 m or 0.45 m Hydrophilic PES
(in case of AseptiCap KS)
Support Layers Polyester
Plastic parts Polypropylene
Size
Size 5 10 20 30
Operational
Max. Operating Temperature 80 C @ < 30 psi (2 Kg/cm)
Max. Differential Pressure 60 psi (4 Kg/cm) @ 30 C
By Gas Sterilizable by Ethylene Oxide
Sterilization
By Autoclave Autoclavable at 125 C for 30minutes, 25 Cycles. Can not be in-line steam sterilized
Shelf Life 3 Years after EO Sterilization
Assurance
Toxicity Passes Bioreactivity test, In vivo, as per USP for Class VI plastics
Cytotoxicity Passes Biological Reactivity Tests, In vitro, USP <87> for cytotoxicity
Bacterial Retention LRV> 7 for B. diminuta (ATCC 19146) per cm of filter area as per ASTM F 838-05
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush
pH Compatibility Compatible with pH range of 1 - 10
Extractables with WFI Passes test as per USP
Indirect Food Additives Comply with USFDA 21 CFR Part 177.1520
Oxidizable Substances Within limits as specified in USP
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
DST DKSLKSX1135L 10
8
Typical Water Flow Rates Datasheet
0.2 m AseptiCap KL/KS (with Prefilter)
0.6 8.0
8.0
4.0 4.0
0.2 0.2
2.0 2.0
1 Capsule Filters
30.0 30.0
2.0 2.0
25.0 25.0
1.5 1.5
20.0 20.0
10.0 10.0
0.5 0.5
5.0 5.0
B: Stepped Hose Barb (for 50mm only) MN: End Connections: Female Luer Lock Inlet/Male Luer Slip Out let
DST DKSLKSX1135L 11
Water Flow Rates Datasheet
0.2 m AseptiCap KL/KS (with Prefilter)
2 Capsule Filters
30.0
30.0 2.0
2.0
25.0
25.0
1.5 1.5
20.0 20.0
End Connections: AA
5 Capsule Filters
30.0 30.0
2.0 2.0
25.0 25.0
1.6 1.6
Pressure Drop (psi)
20.0 20.0
1.2 1.2
15.0 15.0
0.8 0.8
10.0 10.0
A: Stepped Hose Barb Q: Single Step Hose Barb E: 1 Sanitary Flange J: Quick Connector S: Sanitary Flange
DST DKSLKSX1135L 12
Water Flow Rates Datasheet
0.2 m AseptiCap KL/KS (with Prefilter)
8 Capsule Filters
30.0 30.0
2.0 2.0
10.0 10.0
0.5 0.5
5.0 5.0
30.0 30.0
2.0 2.0
25.0 25.0
Pressure Drop(Kg/cm)
1.6 1.6
Pressure Drop (psi)
20.0 20.0
1.2 1.2
15.0 15.0
0.8 0.8
10.0 10.0
A: Stepped Hose Barb Q: Single Step Hose Barb E: 1 Sanitary Flange J: Quick Connector S: Sanitary Flange
DST DKSLKSX1135L 13
Ordering Information Datasheet
Example:
IKSX 06 01 MN X X 1 04
Example:
VKSX 10 01 BB X X 1 08
Note: Inlet/Outlet Connections and Pack Sizes available with different diameter filters as follows:
DST DKSLKSX1135L 14
Ordering Information Datasheet
Example:
DKSX 57 01 DD X X 1 01
Bell at Outlet
Size/Length
Inlet/Outlet Available with
1 2 5 8 (Size/Outlet)
Hose Barb
1 Sanitary Flange
Sanitary Flange x
Quick Connector
MNPT x
MNPT (18TPI)
BSP (19 TPI) x x x
BSP (19 TPI) with O-ring x x x
Female Luer Lock x x x
Male Luer Slip Outlet Only x x x
DST DKSLKSX1135L 15
Ordering Information Datasheet
Example:
LKSX 54 01 EE X T 1 01
Inline T-Line
Inlet/Outlet
5 10 20 30 10 20 30
DST DKSLKSX1135L 16