Manufacturing & Wet Lab

About the facility

A facility has been built in around 4000 sq ft are at an Industrial town of Mahape, Navi Mumbai with a view to provide set up for carrying out various laboratory activities in the field of molecular biology and basic research in life science. It also has a dedicated area with all necessary setup for production /manufacturing of products in this filed.

The facility has been designed, qualified and approved by a QC and Audit teams from our counterpart in PSS, Japan.

Products currently being produced from this facility are :

  • Magnetic bead based Nucleic Acid extraction kits from various sample types like Blood, Tissue, cells, forensic samples etc.. in association with PSS, Japan.
  • BioLiPA NTM/ MDR TB Detection Assay kit
  • Chikungunya LAMP kit

Mission Statement

  • To develop, work with key user groups, co-develop, upscale, produce, commercialize and market advanced, efficient, user-friendly, cost-effective products to support decisions in Molecular Healthcare practices & Life Sciences Basic Research.
  • To achieve excellence in manufacturing by progressively improving quality and standards of products offered so as to meet and exceed customer expectations
  • To continually improve utilizing quality practices through involvement of qualified People.

Production Facility

A dedicated and isolated area in the facility has been constructed for the production of various products that fall under molecular biology/diagnostics including reagents, assay kits and instruments. The area has been divided into separate sections like Gowning area, Raw material storage area, Clean air room, Assembly room and finished storage room. All these rooms are designed and constructed as per industry standards. The partitions, floorings and ceiling have been specially done considering the kind of activity that will be carrying out in those rooms. The rooms have 50mm wall panels made up of powder coated GSS sheets on both side, bonded to high density PUF sandwiched between both the sheets and all corners sides covered to avoid just accumulations. Epoxy coated floorings and ceiling made up of 50mm thick walkable panels.

Clean air room

A Class 100000 clean air room of around 300 Sq.ft area has been built for production activities in a clean environment. This clean room meets all quality standards and has been maintained to achieve less than 3000 class in the room eventhough it has been built for 100k class. Temperature, air pressure, humidity and dust particles are all well maintained in this room. The man entry and exit to this room is through controlled heap air filtered Air Shower and materials are passed thorough Dynamic Pass boxes. There are two Class 100 Laminar air flow systems installed in this clean room give better workspace for production activities.

The production facility has many necessary equipments/instruments like Autoclaves, Dry heat sterilizers, RO water system, sealing and packing systems. All systems are validated and calibrated as per standards and are well maintained.

QC / Laboratory Facility

This facility has dedicated rooms for Nucleic Acid Extraction, a separate section for handling culture samples in a biosafety cabinet, a separate room for NA Amplification and detection. The QC activities for the production done at the facility will be carried out in this laboratory. The facility also provides setup for research work, assay development work, troubleshooting and other routine laboratory related activities.

There are many instruments/equipments installed in this facility and few are listed below:

  • Automated NA Extraction System
  • Biosafety Cabinet with Viral Burnout
  • Incubator Shaker
  • Centrifuge, Refrigerated Centrifuge
  • Electronic Balance
  • PH Meter
  • Spectrophotometers
  • Thermal Cycler
  • Realtime PCR Thermal Cycler
  • LAMP assay detection system
  • Gel Documentation system
  • Electrophoresis & Power supply units
  • Multilabel (Fluoresce/Luminescence/Abs) Microplate reader

1800 267 0607

+91-22-2528 1012

info@biotronhealthcare.com

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