UA-44035381-1
Change Notice ID Notice # Notice Year Product Family Description Download Link
180 MB/09/09 2009 Sterility Check Systems Change in mdi Closed Sterility Test Device Stericheck (All types). Download
181 MB/09/08 2009 Sterility Check Systems Change in mdi Closed Sterility Test Device Stericheck-V (All types). Download
182 MB/09/07 2009 Sterility Check Systems Change in mdi Closed Sterility Test Device Stericheck (All types). Download
183 MB/09/06 2009 Sterility Check Systems Change in mdi Closed Sterility Test Device Stericheck-C and Stericheck-N(All types). Download
184 MB/09/05 2009 Sterility Check Systems Change in mdi Closed Sterility Test Device Stericheck (All types). Download
185 MB/09/04 2009 Sterility Check Systems Change in mdi Closed Sterility Test Device Stericheck Type PC (All membrane types). Download
186 MB/09/03 2009 Sterility Check Systems Change in mdi Closed Sterility Test Device Stericheck (All types). Download
187 MB/09/02 2009 Sterility Check Systems Change in mdi Closed Sterility Test Device Stericheck Type SVP2 (All Membrane Types) Download
188 CP/09/03 2009 Capsule/Cartridge/Disc FIlters Change in Minimum Bubble Point test specification for mdi Polyethersulfone membrane products. Download
189 SL/10/01 2010 Syringe Filters Change in Labelling of mdi Syringe Filters (All types). Download
190 MB/10/01 2010 Disc Filters Change in Grid Printing of mdi Grid Marked Membrane Disc Filters. Download
191 CP/10/02 2010 Capsule Filters Change in the specification of autoclave cycles for mdi PTFE membrane capsule filters. Download
192 DP/10/01 2010 Diagnostic Products

Change in Certificate of Quality for mdi Polyester Backed Nitrocellulose Membrane Type CNPH, CNPC and CNPF.

Download
193 MB/10/02 2010 Sterility Check Systems

Change in mdi Closed Sterility Test Device type Stericheck-C and Stericheck-V (All types).

Download
194 CP/10/03 2010 Capsule Filters New design of drain valve and vent valve in mdi capsule filters of length 2 inch, 5 inch and 10 inch (All types and all pore sizes). Download
195 CP/10/04 2010 Capsule Filters New packaging box for mdi capsule filters of length 2 inch, 5 inch and 10 inch (All types and all pore sizes). Download
196 MB/10/03 2010 Sterility Check Systems Change in mdi Closed Sterility Test Device type Stericheck-LVP (All membrane Types). Download
197 MB/10/04 2010 Sterility Check Systems Change in mdi Closed Sterility Test Device type Stericheck (All Types). Download
198 SL/10/02 2010 Syringe Filters Outer Ring Color Change of mdi Syringe Filters Type SYTG/0.2 µm (25 mm and 13 mm) Download
199 MB/11/01 2011 Sterility Check Systems Change in mdi Closed Sterility Test Device Stericheck (All types). Download
200 MB/11/02 2011 Sterility Check Systems Change in mdi Closed Sterility Test Device type Stericheck (All types) Download
201 MB/11/03 2011 Sterility Check Systems Change in mdi Closed Sterility Test Device type Stericheck-SVP2 (All membrane types) Download
202 SL/11/01 2011 Syringe Filters Change in Printing Matter of mdi Syringe Filters Download
204 MB-11-04 2011 Sterility Check Systems Change in mdi Closed Sterility Test Device type Stericheck-SVP1 and Stericheck-SVP3 (All membrane types) Download
205 MB-11-05 2011 Sterility Check Systems Change in Certificate of Quality for mdi Closed Sterility Test Device type Stericheck (All types) Download
206 CP/11/01 2011 Capsule Filters Rationalization of length of 10" Capsule filter (All capsule types) Download
207 DP/11/01 2011 Diagnostic Products Change in Certificate of Quality for mdi Sample Pad type GFB-R Download
208 DP/11/02 2011 Diagnostic Products Change in Certificate of Quality for mdi Conjugate Release Matrix Download
209 CR/11/01 2011 Cartridge Filters Change in Water Intrusion Rate specification for 5" 0.2 µm PTFE Membrane Cartridge Filters type CPTF and CPTH Download
210 DP/12/01 2012 Diagnostic Products Change in Thickness Specification for RBC Separation Membrane (0.35) Download
211 DP/12/02 2012 Diagnostic Products Change in Certificate of Quality for mdi Nitrocellulose Membrane Laminate Type CNPH Download
212 DP/12/03 2012 Diagnostic Products Change in Certificate of Quality for mdi Nitrocellulose Membrane Laminate Type CNPC Download
213 DP/12/04 2012 Diagnostic Products Change in Certificate of Quality for mdi Nitrocellulose Membrane Laminate Type CNPF Download
214 DP/12/05 2012 Diagnostic Products Change in Certificate of Quality for mdi Conjugate Release Matrix Download
215 DP/12/06 2012 Diagnostic Products Change in Certificate of Quality for mdi Sample Pad Type GFB-R Download
216 MB/12/01 2012 Disc Filters Rationalization of pore size of Membrane Disc Filters type CN/0.22 um (all diameters) Download
217 CP/12/01 2012 Capsule Filters Modification in Disc sealing process of 1" Capsule Filter type DKL Download
218 CP/12/02 2012 Capsule Filters Modification in identification on 10 inch Large Capsule Filter (All types) Download
219 MB/12/02 2012 Funnels Improved packaging (outer carton) for mdi Funnel (All types) Download
220 MB/13/01 2013 Funnels Change in Lot numbering system of mdi Funnel (All types) Download
221 DP/13/01 2013 Diagnostic Products Change in Certificate of Quality for mdi RBC Separation Membranes Download
222 CR/13/01 2013 Cartridge Filters Change in Bubble Point Test specification for mdi 0.1 &m Polyethersulfone Membrane Cartridge Filter Download
223 CR/11/01 2011 Cartridge Filters Change in Water Intrusion Rate specification for 5" 0.2 µm PTFE Membrane Cartridge Filters type CPTF and CPTH Download
224 CP/13/01 2013 Capsule Filters Change in Bubble Point Test specification for mdi 0.1 µm Polyethersulfone Membrane Capsule Filter Download
225 CR/13/04 2013 Cartridge Filters Modification in identification on Cartridge Filter (Sizes greater than or equal to 10" Download
226 MB/13/03 2013 Sterility Check Systems Improved/Modified design of Expansion chamber in mdi SVP Diluter (All types) Download
227 CP/13/05 2013 Capsule Filters Improved design of Protective Caps for vent/Drain valve and Inlet/Outlet connection half inch Stepped Hose Barb only used with mdi Capsule Filters Download
228 CP/13/06 2013 Capsule/Cartridges Addition of Cytotoxicity Test to Certificate of Quality for mdi Polyethersulfone membrane Filters Download
229 CP/13/07 2013 Capsule/Cartridges Separate Identification of Serial number and Sterilization cycle number on Certificate of Quality and product label for filters Download
230 CP/13/08 2013 Capsule/Cartridges Assigning Trade Names to the products Download
231 CP/13/09 2013 Capsule Filters Modification in identification on Capsule Filter of length 2", 5" and 8" (All types) Download
232 CP/13/10 2013 All Products Change in Certificate of Quality (CoQ) Download
233 CR/13/05 2013 Cartridge Filters Modification in identification on Cartridge Filter Download
234 MB/13/04 2013 Funnels Change in Certificate of Quality for mdi M-Funnel Download
235 MB/14/01 2014 Disc Filters Change in Lot numbering system of mdi Pre-sterilized Membrane Disc Filters (All types) Download
236 CN/14/01 2014 Cartridge Filters Inclusion of 50% Isopropyl alcohol wetted Bubble Point Test Specification in Certificate of Quality (CoQ) for Nylon Membrane Cartridge Filters (pore sizes: 0.2 3m and 0.45 3 Download
237 CN/14/02 2014 Capsule/Cartridges Assigning Trade Names to the products Download
238 CN/14/03 2014 Capsule/Cartridges Change in Minimum Bubble Point Test Specification for mdi Nylon membrane Filters Download
239 CN/14/04 2014 Cartridge Filters Change in Diffusion Flow Limit for mdi 0.2µm Polyethersulfone membrane Cartridge Filters Download
240 CN/14/05 2014 Capsule Filters Addition/change of specification of sterilization for mdi cartridge and capsule filters Download
241 CN/14/06 2014 Disc Filters Discontinuation of pack size of mdi Cellulose Nitrate Membrane Disc Filters with Ink Grid Download
242 CN/14/07 2014 Sterility Check Systems Improved/Modified design of mdi Stericheck (Closed Sterility Test System) Download
243 CN/14/08 2014 Capsule Filters Improvement/Modification in identification on Inline Filters and Inline Vent Filters Download
244 CN/14/09 2014 Capsule Filters Change in product catalog number of Capsule filter Download
245 CN/15/01 2015 Sterility Check Systems Change in product catalog number of Stericheck Download
246 CN/15/02 2015 Capsule Filters Modification in identification on mdi Inline Filters and Inline Vent Filters Download
247 CN/15/03 2015 Capsule Filters Improved design of Protective Cap for end connection type Single Step 1/2" Hose barb (Code - Q) used with mdi Capsule Filters Download
248 CN/15/04 2015 Cartridge Filters New printing on the packaging box for mdi cartridge filters of length 10 inch, 20 inch and 30 inch with All types and all pore sizes Download
249 CN/15/05 2015 Capsule Filters Improved design of end connection type 1/4" - 3/8" Hose barb (Code - B) used with mdi Inline Filters and Inline Vent Filter Download
250 CN/15/06 2015 Capsule Filters Improvement in the identification of mdi products Download
251 CN/15/07 2015 Capsule Filters Redefining of product expiry date/shelf life of Gamma Irradiated Products Download
252 CN/15/08 2015 Sterility Check Systems Change in Certificate of Quality for mdi Closed Sterility Test Device type Stericheck Download
253 CN/15/09 2015 Capsule Filters Removal of product individual label from mdi Inline Filters and Inline Vent Filters Download
254 CN/15/10 2015 Capsule Filters Change in Autoclaving temperature specification of mdi Capsule Filters Download
255 CN/15/11 2015 Capsule Filters Modification/Improvement in product labeling of mdi 25mm Inline Filters and Inline Vent Filters Download
256 CN/15/13 2015 Capsule/Cartridges Filters Rationalization of product trade names Download
257 CN/15/12 2015 Capsule Filters New printing design of packaging box for mdi Large Capsule Filters of size 10" Download
258 CN/15/14 2015 Disc Filters New printing design of packaging box for mdi Pre-sterilized Membrane Disc Filters Download
259 CN/16/02 2016 Capsule Filters Rationalization of standard pack size of Inline Filters and Inline Vent Filters Download
260 CN/16/03 2016 Capsule Filters Modification in identification on mdi Capsule Filters Download
261 CN/16/01 2016 Capsule Filters Inclusion of Bubble Point Specification with 50% Isopropyl alcohol/water solution in Certificate of Quality (COQ) for Polyethersulfone Membrane Inline Filters Download
262 CN/16/04 2016 Sterility Check Systems Change in Certificate of Quality for mdi Stericheck: Closed Sterility Test System Download
263 CN/16/05 2016 Capsule/Cartridges Filters Assigning Trade Names to products Download
264 CN/16/06 2016 Disc Filters New printing design of packaging box for mdi Disc Filters and Filter Media Strips Download
265 CN/16/07 2016 Capsule Filters Improved design of Protective Cap for Inlet/Outlet connection and Vent/Drain valve of mdi Capsule Filters Download
266 CN/16/08 2016 Capsule Filters Improved design of Inlet/Outlet connection type Female Luer Lock of mdi Capsule Filters Download
267 CN/16/09 2016 Sterility Check Systems Rationalization of product catalog number of mdi Stericheck SVP Dilutor Download
268 CN/16/10 2016 Sterility Check Systems New printing design of packaging box for mdi Stericheck: Closed Sterility Test System Download
269 CN/16/11 2016 Syringe Filters Change in Lot numbering system of mdi pre-sterilized Syringe Filters (All types) Download
270 CN/16/12 2016 Capsule Filters Redefining product expiry date/shelf life of EO Sterilized Capsule Filters Download
271 CN/16/13 2016 Capsule Filters Improved design of end connection type Female Luer Lock of mdi Capsule Filters Download
272 CN/16/14 2016 Capsule Filters New design of vent/drain valves of mdi Large Capsule Filters Download
273 CN/16/15 2016 Capsule Filters Improved product package label (with QR code) for mdi products. Download
274 CN/17/01 2017 Centrifugal Filters Rationalization of product catalog number of mdi Centrifugal Filters. Download
275 CN/17/02 2017 Funnels Improved design of of mdi Funnel (Funnel Base). Download
276 CN/17/03 2017 Cartridge Filters Change in specifications of Maximum Operating Temperature for mdi AseptiSure TH Hydrophobic PTFE Membrane Cartridge Filters. Download
277 CN/17/04 2017 Aseptic Sampling System Changes related to product catalog number, product lot number and certificate of quality of mdi Aseptic Sampling System Download
278 CN/17/05 2017 Centrifugal Filters and Vacufil Change in Lot numbering system and product package label of mdi pre-sterilized Centrifugal Filters and Vacufil Download
279 CN/17/06 2017 Glassfiber Disc Filters and Transfer Mem New printing design of packaging box for mdi Glassfiber Disc Filters and Transfer Membranes Download
280 CN/17/07 2017 Capsule/Cartridge/Disc FIlters Addition of Bacterial Endotoxin and Cytotoxicity in Certificate of Quality for mdi Hydrophilic PVDF Membrane Filters Download
281 CN/17/08 2017 Funnels New printing design of packaging box for mdi Funnel Download
282 CN/17/09 2017 Sterility Check System

Improved Diluent Transfer Needle Assembly of mdi Stericheck: Closed Sterility Test System

Download
286 CN/17/10 2017 Capsule/Cartridge Filters Addition of water wetted Bubble Point Test Specification to the Certificate of Quality (CoQ) of 0.45 um Polyethersulfone (PES) Membrane Cartridge and Capsule Filters of size 10" Download
287 CN/17/11 2017 Disc Filters

New printing design of packaging box for mdi Pre-sterilized Membrane Disc Filters

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288 CN/17/12 2017 Capsule/Cartridge Filters

Addition of pore size rating of different membrane layers (used in multilayered products) to respective Certificate of Quality (CoQ) and Product Package Label

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290 CN/17/13 2017 Capsule Filters

Improvement in identification (Laser etching) on mdi Capsule Filters

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291 CN/17/14 2017 Capsule Filters

New packaging box for mdi Capsule Filters

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292 CN/17/15 2017 Product Inserts

Change in Product Inserts

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293 CN/17/16 2017 ASESS Aseptic Sampling System

Changes related to product catalog number of mdi ASESS Aseptic Sampling System

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294 CN/17/17 2017 PTFE Membrane Filters

Addition of Cytotoxicity in Certificate of Quality for mdi Hydrophobic PTFE Membrane Filters

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295 CN/17/18 2017 Syringe and Inline Filters

New printing design of packaging box for mdi 25mm Pre-sterilized Syringe Filters and Inline Filters

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296 CN/17/19 2017 Inline Filters

Change in autoclaving temperature specification of mdi Inline Filters

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297 CN/17/20 2017 Cartridge Filters

Addition of Bubble Point Test Specification to the Certificate of Quality (CoQ) of mdi Membrane Cartridge Filters with size 20" and 30"

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298 CN/17/21 2017 Funnels

Addition of Microbial Recovery in mdi Funnel

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299 CN/17/22 2017 Vacuum Filtration Devices

Change in Funnel capacity of mdi Vacuum Filter Device

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300 CN/17/23 2017 Capsule/Cartridge Filters

Change in number of sterilization cycles of mdi Pre-filters type ClariPro GK and ClariSure GK

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301 CN/17/24 2017 Inline Filters

Change in Minimum Bubble Point specification for mdi 0.2um AseptiVent TF Hydrophobic PTFE Membrane Inline Filters (25 mm diameter)

Download
302 CN/17/25 2017 Diagnostics

Change in storage temperature of mdi Diagnostic Materials

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303 CN/17/26 2017 Capsule Filters

Change in lot release criteria for nominally rated mdi Capsule filter types BioPro KS and BioPro KSO

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304 CN/17/27 2017 EO Sterilized Products

Change in lot release criteria for mdi pre-sterilized products (EO sterilized)

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305 CN/18/01 2018 Pre-sterilized Syringe Filters

New printing design of packaging box for mdi 13mm and 4mm
Pre-sterilized Syringe Filters

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306 CN/18/02 2018 Inline Filters

New design of vent valve used in mdi 1" length capsule filter and 50 mm diameter Inline Filter with vent.

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307 CN/18/03 2018 Sterility Test Devices

Change in lot release criteria for mdi pre-sterilized Sterility Test Devices (Gamma sterilized)

Download
308 CN/18/04 2018 Pre-sterilized Products

Change in lot release criteria for mdi pre-sterilized Products (Gamma sterilized)

Download
309 CN/18/05 2018 Cartridge Filters

Change in Water Intrusion Rate specification for mdi 0.2um Hydrophobic PTFE Membrane Cartridge Filters type AseptiSure TH (5" Length)

Download
310 CN/18/06 2018 Pre-sterilized products

Addition of sterilization date in Certificate of Quality (CoQ) for mdi pre-sterilized products (EO sterilized and Gamma sterilized)

Download
311 CN/18/07 2018 Gamma sterilized products

Addition of dose value of Gamma radiation in Certificate of Quality (CoQ) for mdi Gamma sterilized products

Download
312 CN/18/08 2018 Single Use Assembly

Addition of used filter details in Certificate of Quality (CoQ) for mdi Single Use Assembly

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313 CN/18/09 2018 Other Products Change in lot release criteria for mdi 0.8 micron rated Products Download
314 CN/18/10 2018 Stericheck Canisters Change in minimum Burst Pressure specification for mdi Stericheck Canisters (Stericheck: Closed Sterility Test System) Download
315 CN/18/11 2018 Inline Filters

Improved design of 1/4" - 3/8" Hose barb connection (Code 'B' in catalog number)used with mdi Inline Filters with Vent

Download
316 CN/18/12 2018 Closed Sterility Test System

Improved design of liquid transfer needle of mdi Stericheck: Closed Sterility Test System

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342 CN/18/13 2018 Diagnostic Products

Updation of the specifications of mdi Diagnostic Products

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343 CN/19/001 2019 Single Use Systems

Change in the inlet/outlet connection of sampling bags used in mdi Single Use Systems

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344 CN/19/002 2019 Containers

New design of seal used to close packaging containers of mdi Products

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345 CN/19/003 2019 Vacuum Filter Unit for Glass Bottles

Change in Funnel capacity of mdi Vacuum Filter Unit for Glass Bottles

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346 CN/19/004 2019 Large Capsule Filters

New design of vent/drain valves of mdi Large Capsule Filters

Download
347 CN/19/005 2019 Single Use Systems

Addition of drawing revision number in product package label and certificate of quality for mdi single use assemblies

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348 CN/19/006 2019 All Products

Addition of Bacterial Endotoxin test (BET) in Certificate of Quality for mdi Products

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349 CN/19/007 2019 0.1µm rated Products

Addition of Bacterial Retention test in Certificate of Quality for mdi 0.1µm rated Products

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350 CN/19/008 2019 0.45µm rated Products

Change in lot release criteria for mdi 0.45µm rated Products

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351 CN/19/009 2019 Quick Connectors

Improved product package label (with QR code) for mdi Quick Connectors

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352 CN/19/010 2019 AseptiVac Vacuum Filters

Colour coding for mdi AseptiVac Vacuum Filters

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353 CN/19/011 2019 Nylon Membrane products

Addition of specifications for sterilization in certificate of Quality (CoQ) of Nylon Membrane products

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354 CN/19/012 2019 Vacuum Filters

Improved product identification of mdi AseptiVac Vacuum Filters

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355 CN/19/013 2019 Funnels

Improved design of mdi Funnel (Funnel Base)

Download
356 CN/F/19/014 2019 Gamma Sterilized Products

Addition of maximum dose specification of Gamma radiations in Certificate of Quality (CoQ) for mdi Gamma sterilized products&l

Download
357 CN/F/19/015 2019 Membrane Disc Filters

Change in Certificate of Quality (CoQ) for mdi Membrane Disc Filters with respect to Microbial Recovery

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358 CN/F/19/016 2019 Large Capsule Filters

Improved design of vent/drain valves of mdi Large Capsule Filters

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359 CN-A/19/001 2019 Single Use Assemblies

Change in the capacity of Bags used in mdi Single Use Assemblies and AseptiBag Gold Assemblies

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360 CN-A/19/002 2019 Aseptibags and AseptiLiners

Addition of volume in Certificate of Quality (COQ) for mdi Aseptibags and AseptiLiners

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361 CN/D/19/001 2019 Diagnostic Products

Change in Certificate of Quality (CoQ) and Labels for mdi Diagnostic Products

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362 CN/F/20/001 2020 Selected Products

Change in the nomenclature of product Flow rates (Water Flow Rates/Air Flow Rates)

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363 CN/F/20/002 2020 Hydrophobic PTFE Membrane Disc Filters

Rationalization of Minimum Acceptable Bubble Point specification of Hydrophobic PTFE Membrane Disc Filters type TF2

Download
364 CN/F/20/003 2020 Inline Filters and Vacufil

New packaging boxes for mdi Inline Filters and Vacufil

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365 CN/F/20/004 2020 mdi Funnels

Improved packaging for mdi Funnels

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366 CN/A/20/002 2020 Single Use Systems

Change in Certificate of Quality for the recommended storage temperature of AseptiBag Gold (Bags) storage and transfer systems and bag assemblies used in mdi

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367 CN/A/20/003 2020 Single Use Systems

Change in the capacity of Bags used in mdi Single Use Assemblies and AseptiBag Gold Assemblies.

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368 CN/A/20/004 2020 Single Use Assemblies

Change in Certificate of Quality regarding the Endotoxin level of Bags and Liners used in mdi Single Use Assemblies and AseptiBag Gold Assemblie

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369 CN/F/20/005 2020 Capsule Filters

Rationalization of the design of capsule housing used in mdi Large Capsule Filter

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370 CN/F/21/001 2021 Non Sterile Products

Addition of manufacturing date and expiry date in Certificate of Quality (CoQ) of mdi non-sterile products

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371 CN/F/21/002 2021 Non Sterile Disc Filters

Redefining product expiry date/shelf life of non-sterile Disc Filters

Download
372 CN/F/21/003 2021 Syringe Filters Re-defining of lot release criteria for PES membrane Syringe Filters Download
373 CN/F/21/004 2021 M-Funnels
Improvement in the methodology used for microbial recovery testing of M-Funnels with black membranes
Download
374 CN/D/21/001 2021 Diagnostics Products

Addition of specifications in Certificate of Quality (CoQ) for mdi Diagnostic Products

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375 CN/D/21/002 2021 Diagnostic Products

Change in Certificate of Quality (CoQ), Labels, and Datasheet for mdi Diagnostic Products

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377 CN/A/21/002 2021 Single Use System

Change in the position of Top ports of 3D bags used in MDI Single Use Assemblies and AseptiBag Gold Assemblies.

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379 CN/F/21/005 2021 All Products

Addition of Total Organic Carbon (TOC) and Conductivity tests in Certificate of Quality for mdi Products

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380 CN/A/21/004 2021 Single Use System

Change in the color of Connectors used in mdi Single Use Assemblies/Systems, AseptiBag Gold Assemblies, and Single Use Components.

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381 CN/A/21/005 2021 Single Use System

Change in the Certificate of Quality and Serial Numbering System used in mdi Single Use Assemblies/Systems.

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382 CN/F/21/007 2021 Cartridge Filters Improved design of Cartridge Filters with adapter code 'Seal-M' Download
383 CN/F/22/001 2022 AseptiSure WS Change in number of SIP cycles for AseptiSure WS Download
384 CN/F/22/002 2022 Quick Connectors Assigning of trade name to Quick Connectors Download
385 CN/F/22/003 2022 Quick Connectors Change in appearance of mdi Quick Connectors Download
386 CN/F/22/004 2022 All Products

Incorporation of manufacturing site address on the Certificate of Quality (CoQ) and Certificate of Sterility (CoS) of mdi products

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387 CN/F/22/005 2022 EO sterile Syringe Filters

Redefining of product expiry date/shelf life of EO sterile Syringe Filters

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388 CN/A/22/001 2022 Single Use Components

Change in the Design of AseptiDlink Connectors used in mdi Single Use Assemblies/Systems, and Single Use Components.

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389 CN/A/22/002 2022 Single Use Components

Change in the design of bottle cap adapters used in mdi Single Use Assemblies/Systems, and Single Use Components.

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391 CN/A/22/003 2022 Single Use Components

Change in the design of septum for sampling port needle used in mdi Single Use Assemblies, ASESS Sampling Systems, and Single Use Components.

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392 CN/A/22/004 2022 Single Use System

Usage of EPE (Expanded Polyethylene) Foam in the packaging of mdi Single Use Systems instead of Air Bubble wrap

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393 CN/F/22/006 2022 Single Use Components Change in appearance of mdi Quick Connectors for better identification Download
394 CN/F/22/007 2022 Capsule Filters Improvement in identification method of product information on mdi Large Capsule Filters Download
395 CN/F/22/008 2022 Disc Filters Change in Lot numbering system of mdi Membrane Disc Filters Download
396 CN/A/22/005 2022 Single Use System A protective sleeve is provided on sampling port of mdi Single Use Assemblies, ASESS Sampling Systems and Single Use Components Download
397 CN/D/22/001 2022 Diagnostic Products

Change in the lot numbering system of all types of NC membrane rolls and laminates of mdi diagnostic products.

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398 CN/F/22/009 2022 Gamma Sterilized Products

Change in sterilization cycle number of mdi Gamma sterilized products

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399 CN/F/22/010 2022 Quick Connectors

Rationalization of catalog numbers of mdi Quick Connectors (Male and Female Plug)

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401 CN/A/23/001 2023 Single Use Assemblies

Change in the trade name of mdi Platinum Cured Silicone tubing from AseptiCone to AseptiFlo used in mdi Single Use Assemblies

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402 CN/A/23/002 2023 Single Use System

Addition of individual Assembly Serial Number in Certificate of Quality (CoQ) of mdi Single Use Assembly/System in which sterilizing grade filter are used

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403 CN/F/23/001 2023 Capsule Filters

Updation of drainage/support layers of mdi Capsule Filter Type BioPro KSO-y

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404 CN/F/23/002 2023 Single Use System

Addition of Cytotoxicity (USP <87>) in documentation related to mdi PES Membrane Filters.

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405 CN/F/23/003 2023 Stericheck

Improved primary packaging for mdi Stericheck (Closed Sterility Test System)

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406 CN/A/23/003 2023 Single Use System

Usage of Laminated EPE (Expanded Polyethylene) foam in the packaging of mdi Single Use Assemblies/Systems instead of Plain EPE (Expanded Polyethylene) foam

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407 CN/F/23/004 2023 Small Capsule Filters

Rationalization of primary packaging of autoclavable non-sterile small capsule filters packed in poly pouches

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408 CN/A/23/004 2023 Single Use Assemblies

Change in height of mdi 8" TC port used in mdi Single Use Assemblies.

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409 CN/A/23/005 2023 Single Use Hardware

Improvement of mdi SS Trolley and liner drum

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410 CN/F/23/005 2023 Stericheck

Change in lot release criteria for mdi Stericheck

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411 CN/F/23/006 2023 Filter Plates

Rationalization of catalog numbers of mdi Filter Plates

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412 CN/A/23/006 2023 Single Use Filter Assemblies and Single Use Bag Assemblies

Usage of Oetiker Clamps instead of wire ties in mdi Single Use Filter Assemblies and Single Use Bag Assemblies having tubing with Inner Diameter >12.7mm.

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413 CN/D/24/001 2024 Diagnostic Products

Change in the inner box packaging for product type-Blood separation membrane (FR), Flow through membrane (CLW), Conjugate release matrix (PT), Sample pad (GFB) for all strip form of materials of mdi diagnostic products.

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414 CN/A/24/001 2024 Single Use Assemblies Addition of manufacturing and expiration date in Certificate of Quality (CoQ) of mdi non sterile Single Use Assemblies. Download
415 CN/F/24/001 2024 Hydrophilic membrane filters Change in lot release criteria for mdi Hydrophilic membrane filters Download
416 CN/F/24/002 2024 0.1µm filters Change in micro-organism used for microbial/bacterial retention test of 0.1µm filters Download
417 CN/F/24/003 2024 PES and PVDF membrane filters

Tightening of 50% IPA/Water solution wetted minimum bubble point specification for mdi 0.2µm Polyethersulfone (PES) and hydrophilic PVDF membrane filters

Download
418 CN/D/24/002 2024 Diagnostic Products Improved product package label (with QR code) for mdi diagnostic products. Download
419 CN/F/24/004 2024 PES Membrane Filters Changes in integrity test specifications of mdi 0.1µm rated PES membrane filters Download
420 CN/F/24/005 2024 PVDF Membrane Filters Changes in integrity test specifications of mdi 0.1µm rated hydrophilic PVDF membrane filters Download
421 CN/F/24/006 2024 0.1µm rated membrane filters Change in micro-organism used for microbial/bacterial retention test of 0.1µm rated membrane filters Download
422 CN/H/24/001 2024 Glass Bottles Change in 500 mL glass bottle and 33 mm rubber bung Download
423 CN/F/24/007 2024 Capsule Filters Change in design of vent/drain valves used in mdi capsule filters Download
424 CN/A/24/002 2024 Single Use System

Harmonization of Certificate of Quality for AseptiLiner w.r.t

  • Revision of Endotoxin level specifications
  • Addition of Revision Number
Download
425 CN/F/24/008 2024 Stericheck: Closed sterility test system Improvement primary blister packaging of mdi Stericheck: Closed sterility test system Download
426 CN/A/24/003 2024 Single Use System Harmonization of Certificate of Quality for AseptiLiner w.r.t
  • Revision of Endotoxin level specifications
  • Addition of Revision Number
Download
427 CI/F/24/009 2024 Cartridge filters

Use of new mdi facility for manufacturing of mdi Polypropylene cartridge filters and Microglassfiber cartridge filters

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428 CN/F/24/009 2024 Harvester Funnels

Updation of filtration area of mdi Harvester Funnels

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429 CN/F/24/010 2024 Filters

Improvement in the identification on mdi filters

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430 CN/F/24/010 (Rev-01) 2024 Filters Improvement in the identification on mdi filters Download
431 CN/F/24/011 2024 Non sterile products Addition of expiry in product label of mdi non sterile products Download
432 CN/D/24/003 2024 Diagnostic Products Improvement in aluminium pouch packaging for mdi diagnostic products. Download
433 CN/F/24/012 2024 MDI Products Use of mdi gamma irradiation facility for sterilization of mdi products Download
434 CN/A/24/004 2024 Single Use Assemblies Change in design of AseptiFit fittings used as components in Single Use Assemblies Download
435 CN/A/24/005 2024 Single Use Assemblies Addition of expiry in product label of mdi non-sterile AseptiLiner and Single Use Assembly. Download