Manufacturing Facility:

Our facility is situated at Roorkee, Uttarakhand, India and has the manufacturing abilities to offer formulation in Tablets, Capsules and Oral Liquids.
Project is designed to follow the guidelines of WHO-GMP. Air to all the areas is supplied through dedicated AHUs with terminal HEPA filters at the product exposure areas.
Area of plant is approx 4000 sq. meters, with green environment in surroundings.Storage areas for raw materials, packing materials and finished goods have controlled temperature conditions.
A Purified Water System is installed & qualified to meet IP & EP standards.The facility has a well equipped quality control laboratory managed as per Good Laboratory Practices. All our quality systems are managed by highly experienced skilled Quality Assurance team.
We emphasize on ongoing training to the personnel as a step towards upholding excellence in manufacturing. Unit is constructed on Uni-flow process layout with separate entry for man and material hence no criss-cross movement.

Technical Services

  • Handling the critical support system like HVAC, water purification system with required standards and their validation complying standards like WHO-GMP.
  • Trugen’s unique product & service offerings combined with manufacturing flexibility enables it to create customised fortification solutions.
  • Separate and hygienically card for, in & out flow of man and material at all levels.

Environmental

Waste Water Management

The site has a separate effluent treatment plant 5000 Liters per Hour for the treatment of composite effluent by the use of RO System with Sand filters and Chemicals as Alum, Polyelectrolyte, and Lime in particular concentration to get the outlet Water quality as per the laid down specifications by the Governing authorities by testing the samples In the in House Laboratories and Time to time by Government Approved Laboratories. Only treated effluent is discharged from the site. The treated Water is supplied in to open land in the premises to grow plants. The company complies with the requirement of the Uttarakhand Pollution Control Board/ Central Pollution Control Board.
Our Waste Water Management System is designed to handle Pharmaceutical wastewaters including but not limited to:

  • Acid/ Alkali Rinses
  • Oil Separation

Our system selection criteria are guided by four factors, contributing to the size, complexity, and cost of the system:

  • Pollutant Type - Effective removal of pollutants from the wastewater.
  • Pollutant Loading - Minimization of chemical costs/ solids handling equipment.
  • Hydraulic Flow Rates - Determinant in size and capital costs of wastewater treatment system.
  • Environmental Regulations - Often the leading criterion in design of wastewater treatment processes and systems.

Our treatment system components typically include:

  • Coagulation/ Neutralization - Chemical reaction stages
  • Flocculation/ Clarification - Polymer addition and solids separation
  • Effluent polishing - Sand filters
  • Sludge Thickening and Dewatering - Settling tanks and filter presses

Hazardous Waste Management

At TRUGEN, Quality Control Lab following analysis are performed for Hazardous Waste Management.

  • Evaluation of solid waste for hazardous constituents including heavy metals, pesticides & organic constituents
  • Evaluation of used & waste oil for PCB’S and PAH & Schedule V & VI of CPCB.
  • Electronic waste as per WEEE / ROHS Directives.
  • Composition & heat value of wastes
  • Leachability studies on wastes
  • Analysis of hazardous waste as per
    • Flammability of waste materials
    • Packaging wastes as per EC directive
    • Hazardous waste as per USEPA & EWS-846
    • Instruments used: ICP-MS, ICP-OES, GC-MS, GC-ECD/NPD, GC-TCD/FID, HPLC-UV/RI/Fluoro, FTIR, UV-Vis.

PEST CONTROL

Pest And Rodent Control:

Pest and rodent treatment is done to check the cross contamination and to protect the drug and other material from rats termites and rodents. Schedule for termite control is within 15 days which is carried out by the contractor. Treatment controlling the pest in specified area is done within 7 days. Pest repellers have been installed at key locations in stores. Treatment for controlling the rodent in the specified area is done within 7 days and records are maintained.

Air Monitoring

The Manufacturing, Filling and Packing areas are provided with separate Air Handling Units designed to prevent the risk of cross contamination.
In the manufacturing area to maintain the quality of environment Differential air pressures are maintained in adjacent manufacturing sections as per the process requirements.
The details of design criteria i.e. air supply, temperature, humidity, number of air changes and room pressure of air handling system for critical manufacturing areas are as per the guidelines given by the governing authorities Configuration of filters for critical manufacturing areas are 5 micron prefilters, 3 micron fine filters.
All corridors in production area are maintained at positive pressure with respect to adjacent processing area to avoid cross contamination.
Microbiological laboratory work and Sampling / dispensing of Raw materials is carried out under Reverse Laminar.

Filter Design & efficiency

Type of filter Specification Efficiency
Prefilter5 micron 90 %
Final Filter3 micron 90 %

Limit for filter change

Type of filter Limit
PrefilterPhysically found damage or un-cleanable or after 2 years.
Final FilterAfter 2 years or physically found damage or pressure drop.

A DOP test point is provided in LAF.

Frequency of revalidation of HVAC system and RLAF are yearly for air velocity, air changes and particle count.