UA-44035381-1
Notice # | Notice Year | Product Family | Description | Download Link |
---|---|---|---|---|
MB/09/09 | 2009 | Sterility Check Systems | Change in mdi Closed Sterility Test Device Stericheck (All types). | Download |
MB/09/08 | 2009 | Sterility Check Systems | Change in mdi Closed Sterility Test Device Stericheck-V (All types). | Download |
MB/09/07 | 2009 | Sterility Check Systems | Change in mdi Closed Sterility Test Device Stericheck (All types). | Download |
MB/09/06 | 2009 | Sterility Check Systems | Change in mdi Closed Sterility Test Device Stericheck-C and Stericheck-N(All types). | Download |
MB/09/05 | 2009 | Sterility Check Systems | Change in mdi Closed Sterility Test Device Stericheck (All types). | Download |
MB/09/04 | 2009 | Sterility Check Systems | Change in mdi Closed Sterility Test Device Stericheck Type PC (All membrane types). | Download |
MB/09/03 | 2009 | Sterility Check Systems | Change in mdi Closed Sterility Test Device Stericheck (All types). | Download |
MB/09/02 | 2009 | Sterility Check Systems | Change in mdi Closed Sterility Test Device Stericheck Type SVP2 (All Membrane Types) | Download |
CP/09/03 | 2009 | Capsule/Cartridge/Disc FIlters | Change in Minimum Bubble Point test specification for mdi Polyethersulfone membrane products. | Download |
SL/10/01 | 2010 | Syringe Filters | Change in Labelling of mdi Syringe Filters (All types). | Download |
MB/10/01 | 2010 | Disc Filters | Change in Grid Printing of mdi Grid Marked Membrane Disc Filters. | Download |
CP/10/02 | 2010 | Capsule Filters | Change in the specification of autoclave cycles for mdi PTFE membrane capsule filters. | Download |
DP/10/01 | 2010 | Diagnostic Products | Change in Certificate of Quality for mdi Polyester Backed Nitrocellulose Membrane Type CNPH, CNPC and CNPF. |
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MB/10/02 | 2010 | Sterility Check Systems | Change in mdi Closed Sterility Test Device type Stericheck-C and Stericheck-V (All types). |
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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 |
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 |
MB/10/03 | 2010 | Sterility Check Systems | Change in mdi Closed Sterility Test Device type Stericheck-LVP (All membrane Types). | Download |
MB/10/04 | 2010 | Sterility Check Systems | Change in mdi Closed Sterility Test Device type Stericheck (All Types). | Download |
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 |
MB/11/01 | 2011 | Sterility Check Systems | Change in mdi Closed Sterility Test Device Stericheck (All types). | Download |
MB/11/02 | 2011 | Sterility Check Systems | Change in mdi Closed Sterility Test Device type Stericheck (All types) | Download |
MB/11/03 | 2011 | Sterility Check Systems | Change in mdi Closed Sterility Test Device type Stericheck-SVP2 (All membrane types) | Download |
SL/11/01 | 2011 | Syringe Filters | Change in Printing Matter of mdi Syringe Filters | Download |
MB-11-04 | 2011 | Sterility Check Systems | Change in mdi Closed Sterility Test Device type Stericheck-SVP1 and Stericheck-SVP3 (All membrane types) | Download |
MB-11-05 | 2011 | Sterility Check Systems | Change in Certificate of Quality for mdi Closed Sterility Test Device type Stericheck (All types) | Download |
CP/11/01 | 2011 | Capsule Filters | Rationalization of length of 10" Capsule filter (All capsule types) | Download |
DP/11/01 | 2011 | Diagnostic Products | Change in Certificate of Quality for mdi Sample Pad type GFB-R | Download |
DP/11/02 | 2011 | Diagnostic Products | Change in Certificate of Quality for mdi Conjugate Release Matrix | Download |
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 |
DP/12/01 | 2012 | Diagnostic Products | Change in Thickness Specification for RBC Separation Membrane (0.35) | Download |
DP/12/02 | 2012 | Diagnostic Products | Change in Certificate of Quality for mdi Nitrocellulose Membrane Laminate Type CNPH | Download |
DP/12/03 | 2012 | Diagnostic Products | Change in Certificate of Quality for mdi Nitrocellulose Membrane Laminate Type CNPC | Download |
DP/12/04 | 2012 | Diagnostic Products | Change in Certificate of Quality for mdi Nitrocellulose Membrane Laminate Type CNPF | Download |
DP/12/05 | 2012 | Diagnostic Products | Change in Certificate of Quality for mdi Conjugate Release Matrix | Download |
DP/12/06 | 2012 | Diagnostic Products | Change in Certificate of Quality for mdi Sample Pad Type GFB-R | Download |
MB/12/01 | 2012 | Disc Filters | Rationalization of pore size of Membrane Disc Filters type CN/0.22 um (all diameters) | Download |
CP/12/01 | 2012 | Capsule Filters | Modification in Disc sealing process of 1" Capsule Filter type DKL | Download |
CP/12/02 | 2012 | Capsule Filters | Modification in identification on 10 inch Large Capsule Filter (All types) | Download |
MB/12/02 | 2012 | Funnels | Improved packaging (outer carton) for mdi Funnel (All types) | Download |
MB/13/01 | 2013 | Funnels | Change in Lot numbering system of mdi Funnel (All types) | Download |
DP/13/01 | 2013 | Diagnostic Products | Change in Certificate of Quality for mdi RBC Separation Membranes | Download |
CR/13/01 | 2013 | Cartridge Filters | Change in Bubble Point Test specification for mdi 0.1 &m Polyethersulfone Membrane Cartridge Filter | Download |
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 |
CP/13/01 | 2013 | Capsule Filters | Change in Bubble Point Test specification for mdi 0.1 µm Polyethersulfone Membrane Capsule Filter | Download |
CR/13/04 | 2013 | Cartridge Filters | Modification in identification on Cartridge Filter (Sizes greater than or equal to 10" | Download |
MB/13/03 | 2013 | Sterility Check Systems | Improved/Modified design of Expansion chamber in mdi SVP Diluter (All types) | Download |
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 |
CP/13/06 | 2013 | Capsule/Cartridges | Addition of Cytotoxicity Test to Certificate of Quality for mdi Polyethersulfone membrane Filters | Download |
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 |
CP/13/08 | 2013 | Capsule/Cartridges | Assigning Trade Names to the products | Download |
CP/13/09 | 2013 | Capsule Filters | Modification in identification on Capsule Filter of length 2", 5" and 8" (All types) | Download |
CP/13/10 | 2013 | All Products | Change in Certificate of Quality (CoQ) | Download |
CR/13/05 | 2013 | Cartridge Filters | Modification in identification on Cartridge Filter | Download |
MB/13/04 | 2013 | Funnels | Change in Certificate of Quality for mdi M-Funnel | Download |
MB/14/01 | 2014 | Disc Filters | Change in Lot numbering system of mdi Pre-sterilized Membrane Disc Filters (All types) | Download |
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 |
CN/14/02 | 2014 | Capsule/Cartridges | Assigning Trade Names to the products | Download |
CN/14/03 | 2014 | Capsule/Cartridges | Change in Minimum Bubble Point Test Specification for mdi Nylon membrane Filters | Download |
CN/14/04 | 2014 | Cartridge Filters | Change in Diffusion Flow Limit for mdi 0.2µm Polyethersulfone membrane Cartridge Filters | Download |
CN/14/05 | 2014 | Capsule Filters | Addition/change of specification of sterilization for mdi cartridge and capsule filters | Download |
CN/14/06 | 2014 | Disc Filters | Discontinuation of pack size of mdi Cellulose Nitrate Membrane Disc Filters with Ink Grid | Download |
CN/14/07 | 2014 | Sterility Check Systems | Improved/Modified design of mdi Stericheck (Closed Sterility Test System) | Download |
CN/14/08 | 2014 | Capsule Filters | Improvement/Modification in identification on Inline Filters and Inline Vent Filters | Download |
CN/14/09 | 2014 | Capsule Filters | Change in product catalog number of Capsule filter | Download |
CN/15/01 | 2015 | Sterility Check Systems | Change in product catalog number of Stericheck | Download |
CN/15/02 | 2015 | Capsule Filters | Modification in identification on mdi Inline Filters and Inline Vent Filters | Download |
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 |
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 |
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 |
CN/15/06 | 2015 | Capsule Filters | Improvement in the identification of mdi products | Download |
CN/15/07 | 2015 | Capsule Filters | Redefining of product expiry date/shelf life of Gamma Irradiated Products | Download |
CN/15/08 | 2015 | Sterility Check Systems | Change in Certificate of Quality for mdi Closed Sterility Test Device type Stericheck | Download |
CN/15/09 | 2015 | Capsule Filters | Removal of product individual label from mdi Inline Filters and Inline Vent Filters | Download |
CN/15/10 | 2015 | Capsule Filters | Change in Autoclaving temperature specification of mdi Capsule Filters | Download |
CN/15/11 | 2015 | Capsule Filters | Modification/Improvement in product labeling of mdi 25mm Inline Filters and Inline Vent Filters | Download |
CN/15/13 | 2015 | Capsule/Cartridges Filters | Rationalization of product trade names | Download |
CN/15/12 | 2015 | Capsule Filters | New printing design of packaging box for mdi Large Capsule Filters of size 10" | Download |
CN/15/14 | 2015 | Disc Filters | New printing design of packaging box for mdi Pre-sterilized Membrane Disc Filters | Download |
CN/16/02 | 2016 | Capsule Filters | Rationalization of standard pack size of Inline Filters and Inline Vent Filters | Download |
CN/16/03 | 2016 | Capsule Filters | Modification in identification on mdi Capsule Filters | Download |
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 |
CN/16/04 | 2016 | Sterility Check Systems | Change in Certificate of Quality for mdi Stericheck: Closed Sterility Test System | Download |
CN/16/05 | 2016 | Capsule/Cartridges Filters | Assigning Trade Names to products | Download |
CN/16/06 | 2016 | Disc Filters | New printing design of packaging box for mdi Disc Filters and Filter Media Strips | Download |
CN/16/07 | 2016 | Capsule Filters | Improved design of Protective Cap for Inlet/Outlet connection and Vent/Drain valve of mdi Capsule Filters | Download |
CN/16/08 | 2016 | Capsule Filters | Improved design of Inlet/Outlet connection type Female Luer Lock of mdi Capsule Filters | Download |
CN/16/09 | 2016 | Sterility Check Systems | Rationalization of product catalog number of mdi Stericheck SVP Dilutor | Download |
CN/16/10 | 2016 | Sterility Check Systems | New printing design of packaging box for mdi Stericheck: Closed Sterility Test System | Download |
CN/16/11 | 2016 | Syringe Filters | Change in Lot numbering system of mdi pre-sterilized Syringe Filters (All types) | Download |
CN/16/12 | 2016 | Capsule Filters | Redefining product expiry date/shelf life of EO Sterilized Capsule Filters | Download |
CN/16/13 | 2016 | Capsule Filters | Improved design of end connection type Female Luer Lock of mdi Capsule Filters | Download |
CN/16/14 | 2016 | Capsule Filters | New design of vent/drain valves of mdi Large Capsule Filters | Download |
CN/16/15 | 2016 | Capsule Filters | Improved product package label (with QR code) for mdi products. | Download |
CN/17/01 | 2017 | Centrifugal Filters | Rationalization of product catalog number of mdi Centrifugal Filters. | Download |
CN/17/02 | 2017 | Funnels | Improved design of of mdi Funnel (Funnel Base). | Download |
CN/17/03 | 2017 | Cartridge Filters | Change in specifications of Maximum Operating Temperature for mdi AseptiSure TH Hydrophobic PTFE Membrane Cartridge Filters. | Download |
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 |
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 |
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 |
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 |
CN/17/08 | 2017 | Funnels | New printing design of packaging box for mdi Funnel | Download |
CN/17/09 | 2017 | Sterility Check System | Improved Diluent Transfer Needle Assembly of mdi Stericheck: Closed Sterility Test System |
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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 |
CN/17/11 | 2017 | Disc Filters | New printing design of packaging box for mdi Pre-sterilized Membrane Disc Filters |
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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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CN/17/13 | 2017 | Capsule Filters | Improvement in identification (Laser etching) on mdi Capsule Filters |
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CN/17/14 | 2017 | Capsule Filters | New packaging box for mdi Capsule Filters |
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CN/17/15 | 2017 | Product Inserts | Change in Product Inserts |
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CN/17/16 | 2017 | ASESS Aseptic Sampling System | Changes related to product catalog number of mdi ASESS Aseptic Sampling System |
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CN/17/17 | 2017 | PTFE Membrane Filters | Addition of Cytotoxicity in Certificate of Quality for mdi Hydrophobic PTFE Membrane Filters |
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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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CN/17/19 | 2017 | Inline Filters | Change in autoclaving temperature specification of mdi Inline Filters |
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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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CN/17/21 | 2017 | Funnels | Addition of Microbial Recovery in mdi Funnel |
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CN/17/22 | 2017 | Vacuum Filtration Devices | Change in Funnel capacity of mdi Vacuum Filter Device |
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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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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) |
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CN/17/25 | 2017 | Diagnostics | Change in storage temperature of mdi Diagnostic Materials |
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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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CN/17/27 | 2017 | EO Sterilized Products | Change in lot release criteria for mdi pre-sterilized products (EO sterilized) |
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CN/18/01 | 2018 | Pre-sterilized Syringe Filters | New printing design of packaging box for mdi 13mm and 4mm |
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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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CN/18/03 | 2018 | Sterility Test Devices | Change in lot release criteria for mdi pre-sterilized Sterility Test Devices (Gamma sterilized) |
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CN/18/04 | 2018 | Pre-sterilized Products | Change in lot release criteria for mdi pre-sterilized Products (Gamma sterilized) |
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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 |
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) |
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CN/18/07 | 2018 | Gamma sterilized products | Addition of dose value of Gamma radiation in Certificate of Quality (CoQ) for mdi Gamma sterilized products |
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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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CN/18/09 | 2018 | Other Products | Change in lot release criteria for mdi 0.8 micron rated Products | Download |
CN/18/10 | 2018 | Stericheck Canisters | Change in minimum Burst Pressure specification for mdi Stericheck Canisters (Stericheck: Closed Sterility Test System) | Download |
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 |
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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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CN/18/13 | 2018 | Diagnostic Products | Updation of the specifications of mdi Diagnostic Products |
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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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CN/19/002 | 2019 | Containers | New design of seal used to close packaging containers of mdi Products |
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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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CN/19/004 | 2019 | Large Capsule Filters | New design of vent/drain valves of mdi Large Capsule Filters |
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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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CN/19/006 | 2019 | All Products | Addition of Bacterial Endotoxin test (BET) in Certificate of Quality for mdi Products |
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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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CN/19/008 | 2019 | 0.45µm rated Products | Change in lot release criteria for mdi 0.45µm rated Products |
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CN/19/009 | 2019 | Quick Connectors | Improved product package label (with QR code) for mdi Quick Connectors |
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CN/19/010 | 2019 | AseptiVac Vacuum Filters | Colour coding for mdi AseptiVac Vacuum Filters |
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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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CN/19/012 | 2019 | Vacuum Filters | Improved product identification of mdi AseptiVac Vacuum Filters |
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CN/19/013 | 2019 | Funnels | Improved design of mdi Funnel (Funnel Base) |
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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 |
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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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CN/F/19/016 | 2019 | Large Capsule Filters | Improved design of vent/drain valves of mdi Large Capsule Filters |
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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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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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CN/D/19/001 | 2019 | Diagnostic Products | Change in Certificate of Quality (CoQ) and Labels for mdi Diagnostic Products |
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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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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 |
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CN/F/20/003 | 2020 | Inline Filters and Vacufil | New packaging boxes for mdi Inline Filters and Vacufil |
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CN/F/20/004 | 2020 | mdi Funnels | Improved packaging for mdi Funnels |
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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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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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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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CN/F/20/005 | 2020 | Capsule Filters | Rationalization of the design of capsule housing used in mdi Large Capsule Filter |
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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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CN/F/21/002 | 2021 | Non Sterile Disc Filters | Redefining product expiry date/shelf life of non-sterile Disc Filters |
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CN/F/21/003 | 2021 | Syringe Filters | Re-defining of lot release criteria for PES membrane Syringe Filters | Download |
CN/F/21/004 | 2021 | M-Funnels | Improvement in the methodology used for microbial recovery testing of M-Funnels with black membranes |
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CN/D/21/001 | 2021 | Diagnostics Products | Addition of specifications in Certificate of Quality (CoQ) for mdi Diagnostic Products |
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CN/D/21/002 | 2021 | Diagnostic Products | Change in Certificate of Quality (CoQ), Labels, and Datasheet for mdi Diagnostic Products |
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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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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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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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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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CN/F/21/007 | 2021 | Cartridge Filters | Improved design of Cartridge Filters with adapter code 'Seal-M' | Download |
CN/F/22/001 | 2022 | AseptiSure WS | Change in number of SIP cycles for AseptiSure WS | Download |
CN/F/22/002 | 2022 | Quick Connectors | Assigning of trade name to Quick Connectors | Download |
CN/F/22/003 | 2022 | Quick Connectors | Change in appearance of mdi Quick Connectors | Download |
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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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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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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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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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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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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CN/F/22/006 | 2022 | Single Use Components | Change in appearance of mdi Quick Connectors for better identification | Download |
CN/F/22/007 | 2022 | Capsule Filters | Improvement in identification method of product information on mdi Large Capsule Filters | Download |
CN/F/22/008 | 2022 | Disc Filters | Change in Lot numbering system of mdi Membrane Disc Filters | Download |
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 |
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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CN/F/22/009 | 2022 | Gamma Sterilized Products | Change in sterilization cycle number of mdi Gamma sterilized products |
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CN/F/22/010 | 2022 | Quick Connectors | Rationalization of catalog numbers of mdi Quick Connectors (Male and Female Plug) |
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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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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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CN/F/23/001 | 2023 | Capsule Filters | Updation of drainage/support layers of mdi Capsule Filter Type BioPro KSO-y |
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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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CN/F/23/003 | 2023 | Stericheck | Improved primary packaging for mdi Stericheck (Closed Sterility Test System) |
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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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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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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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CN/A/23/005 | 2023 | Single Use Hardware | Improvement of mdi SS Trolley and liner drum |
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CN/F/23/005 | 2023 | Stericheck | Change in lot release criteria for mdi Stericheck |
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CN/F/23/006 | 2023 | Filter Plates | Rationalization of catalog numbers of mdi Filter Plates |
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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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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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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 |
CN/F/24/001 | 2024 | Hydrophilic membrane filters | Change in lot release criteria for mdi Hydrophilic membrane filters | Download |
CN/F/24/002 | 2024 | 0.1µm filters | Change in micro-organism used for microbial/bacterial retention test of 0.1µm filters | Download |
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 |
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CN/D/24/002 | 2024 | Diagnostic Products | Improved product package label (with QR code) for mdi diagnostic products. | Download |
CN/F/24/004 | 2024 | PES Membrane Filters | Changes in integrity test specifications of mdi 0.1µm rated PES membrane filters | Download |
CN/F/24/005 | 2024 | PVDF Membrane Filters | Changes in integrity test specifications of mdi 0.1µm rated hydrophilic PVDF membrane filters | Download |
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 |
CN/H/24/001 | 2024 | Glass Bottles | Change in 500 mL glass bottle and 33 mm rubber bung | Download |
CN/F/24/007 | 2024 | Capsule Filters | Change in design of vent/drain valves used in mdi capsule filters | Download |
CN/A/24/002 | 2024 | Single Use System | Harmonization of Certificate of Quality for AseptiLiner w.r.t
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CN/F/24/008 | 2024 | Stericheck: Closed sterility test system | Improvement primary blister packaging of mdi Stericheck: Closed sterility test system | Download |
CN/A/24/003 | 2024 | Single Use System | Harmonization of Certificate of Quality for AseptiLiner w.r.t
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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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CN/F/24/009 | 2024 | Harvester Funnels | Updation of filtration area of mdi Harvester Funnels |
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CN/F/24/010 | 2024 | Filters | Improvement in the identification on mdi filters |
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CN/F/24/010 (Rev-01) | 2024 | Filters | Improvement in the identification on mdi filters | Download |
CN/F/24/011 | 2024 | Non sterile products | Addition of expiry in product label of mdi non sterile products | Download |
CN/D/24/003 | 2024 | Diagnostic Products | Improvement in aluminium pouch packaging for mdi diagnostic products. | Download |
CN/F/24/012 | 2024 | MDI Products | Use of mdi gamma irradiation facility for sterilization of mdi products | Download |
CN/A/24/004 | 2024 | Single Use Assemblies | Change in design of AseptiFit fittings used as components in Single Use Assemblies | Download |
CN/A/24/005 | 2024 | Single Use Assemblies | Addition of expiry in product label of mdi non-sterile AseptiLiner and Single Use Assembly. | Download |