Manufacturing Areas

mdi has 3 manufacturing sites with a total built up area   of 20,000 sq. meters. (200,000 sq. ft.).
mdi products are used in critical applications in pharmaceutical, biopharmaceutical and other industries. In order to meet the expected standards with respect to bioburden, endotoxin levels, particle/fiber release, and contribution to impurity profile from filters, these products are produced and packaged in GMP facilities with ISO class 7 clean room areas certified by external agencies and monitored internally for viable and non-viable particles and air flows. Employee hygiene, change rooms, gowning and continuous monitoring of the areas is an essential part of these facilities.

These facilities have been designed for unidirectional work flow with class 8 corridors around class 7 production areas, with appropriate change rooms for personnel and pass boxes for material movement. The materials of construction allow easy cleaning, prevent build up of dirt and dust.
Well defined and organized clean storage space with separate ISO class 8 storage areas for quarantine and incoming testing is provided and separate finished goods store is situated next to the dispatch section. Transfer of finish goods from manufacturing areas to storage is through pass boxes.

HVAC System

The requirements of safe and efficient workplace with controlled environment for high product quality are ensured by well designed and validated HVAC systems. The system also ensures appropriate pressures in different classified zones. For reliability and efficiency of operation, two stage HEPA filters are used at central location as well as at the end point locations in ISO Class 7 areas.

Building Management System
The entire building is controlled by a central computerized Building Management System which allows the cleanliness, pressure, RH and temperature parameters in all classified zones to be met with efficiency.

Utilities

RO/EDI Water System

Large capacity purified water system has been installed to deliver water equivalent to 'Purified Water' as per USP. A recirculating loop distribution system ensures that critical parameters such as microbial content, pH and conductivity are well controlled. The system has been validated and continuous monitoring and trend analysis assure that quality standards are met.

Compressed Air System

The compressed air used in production areas is conditioned and filtered to meet the requirements of air entering into classified areas. The quality is regularly monitored.

Engineering Support

A well developed machine tool room provides the required engineering support for development of new machines for new processes as well as automation of existing ones. The engineering group also designs and develops the dies and moulds for new plastic components.

Testing labs at mdi

Production at mdi is supported by highly developed test laboratories. These labs are equipped with latest instrumentation and run by highly skilled personnel.

Microbial Test Lab for Bacterial Challenge Testing to test Retention Efficiency of filters, Sterility Testing, Microbial Load Testing, Bacterial Endotoxin Testing, environmental and utilities monitoring and recovery of organisms from various filter products.

Reliability Lab to establish limits of conditions of use of filters and the operation limit of filters

Filter Test Lab to check physical parameters of various filters.

Analytical Lab to measure, detect and identify extractables and leachables from filters, particulate retention efficiency of filters

Protein and DNA Lab for quality control of Nucleic Acid Purification Kits, Transfer Membranes and filters with regard to critical functional parameters such as yield, purity, binding capacity of proteins etc.

Diagnostic Materials Lab for quality control of membranes and other materials for diagnostics.

Microbiology Lab

The microbiology lab include separate areas for bacterial retention testing, sterility testing, microbial limit testing, bacterial endotoxin testing, and culture lab with independent HVAC systems for each, to ensure highest level of controls. These labs are fitted with latest biosafety cabinets and vertical laminar flow benches and dynamic pass boxes and have state of the art, in-house developed test jigs for filter pre-treatment and bacterial challenge testing with online controls.

Validation Lab

Since customers often require filter validations with specific drug products, mdi has set up a dedicated laboratory to provide 'Asertain' Filter Validation Services. The laboratory has the facilities to handle customer samples, including oncology drugs and simulate customer processes related to filter use and report the results as per the requirements of PDA Technical Report 26.