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

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

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

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

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

Improvement in identification (Laser etching) on mdi Capsule Filters

New packaging box for mdi Capsule Filters

Change in Product Inserts

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

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

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

Change in autoclaving temperature specification of mdi Inline Filters

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

Addition of Microbial Recovery in mdi Funnel

Change in Funnel capacity of mdi Vacuum Filter Device

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

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

Change in storage temperature of mdi Diagnostic Materials

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

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

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

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

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

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

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

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

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

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

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

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

Updation of the specifications of mdi Diagnostic Products

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

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

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

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

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

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

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

Change in lot release criteria for mdi 0.45µm rated Products

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

Colour coding for mdi AseptiVac Vacuum Filters

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

Improved product identification of mdi AseptiVac Vacuum Filters

Improved design of mdi Funnel (Funnel Base)

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

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

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

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

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

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

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

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

New packaging boxes for mdi Inline Filters and Vacufil

Improved packaging for mdi Funnels

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Change in sterilization cycle number of mdi Gamma sterilized products

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

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

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

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

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

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

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

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

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

Improvement of mdi SS Trolley and liner drum

Change in lot release criteria for mdi Stericheck

Rationalization of catalog numbers of mdi Filter Plates

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.

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.

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

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

• Revision of Endotoxin level specifications
• Addition of Revision Number

• Revision of Endotoxin level specifications
• Addition of Revision Number

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

Updation of filtration area of mdi Harvester Funnels

Improvement in the identification on mdi filters