Environmental stability chambers & clean cold rooms

GMP Technical Solutions is an ISO 9001:2000 Certified company and is one of the largest manufactures of Demountable Partitioning Systems, Clean Room Doors, Fire Doors, Storage Racks Clean Room Equipments, Stability Chambers, Cold Storages, Environmental Chambers, Laboratory Ovens , Dual Chambers, BOD Incubators, Incubators, Refrigerators & Deep Freezers in the Indian subcontinent.

GMP was established in 2005 under the Indian Companies Act and commenced production on 1st October 2006. GMP Technical Solutions has an 1,20,000 sq. ft. manufacturing area with an overall supportive infrastructural area of 2,50,000 sq. ft. which is fully equipped with the latest CNC/NC manufacturing equipments GMP houses its own epoxy polyester powder coating/wet coating plant and PUF machines for cold room panels.

The strategic location of the facility at the foothills of Himachal Pradesh offers ZERO Excises Duty. This benefits our clients and enables GMP to offer a competitive pricing structure.

The latest state of the art machineries for cutting, bending, punching ensures International product quality and high quality engineered product.

All GMP products are manufactured under one roof and subsequently all metal finishes, assembly are completed in-house. As a result, specific requirements of our Clients can be incorporated into a proposed design/ product requirement.

The capacity of the manufacturing facility results in timely delivery, and prompt technical support is provided by a network of skilled technical persons across India and abroad.

The in-house testing facility with modern test equipments ensures equipment's performance compliance with the relevant regulatory requirements. Our team of highly trained engineers provides installation, validation & after sale service support, including important test and calibration documentation.

To meet the quality criteria of the stability test, the chemical microbiological and physical characteristics of pharmaceutical substances are tested after exposure to temperature and humidity over a defined period. To that end the following climate conditions were established for long term testing acceleration testing and testing of intermediate conditions according to the ICH*Guideline. Testing at intermediate conditions is carried out in case there are deviations between the first two forms of testing.

 

Long Term Testing

At 25C / 60% RH or 30'C/65%RH

 

Accelerated Testing

At 40°C / 75% RH

 

Intermediate Testing

At 30°C / 65% RH The following test conditions were stipulated for pharmaceuticals in semi permeable packing:
Long term testing
At 25C / 40% RH
Accelerated testing
At 40'C / <25% RH

During the entire test, the deviation in temperature is stipulated at ±2°C and the deviation in relative humidity is stipulated at t5%RH.

According to the ICH guideline , stability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances and pharmaceuticals. In cooperation with the pharmaceutical industry, we have developed a specific range of test cabinets and test chambers to meet these requirements. Stability tests are an important step in the development of new drugs and pharmaceutical substances and an indispensable element in the licensing process defined by federal regulating authorities. However, these tests are just as important for safeguarding the quality of the product within the framework of quality assurance. Together with committees from the pharmaceutical industry, experts from the licensing authorities (such as the FDA) have developed the ICH guidelines for the harmonization of stability tests. These guidelines define standardized storage and batch evaluation as well as the time sequence of the required analytic tests.

Productivity Diversity
Our comprehensive standard line of climate chambers with workspaces ranging from 50 Lit. to 2000 Lit as well as custom sized walk in test chambers are available for the execution of stability tests. In specific cases, a stability chamber can be adapted to the actual space that is available.

 

Documentation

For recording the measurement values of temperature and humidity, numerous documentation options are available in accordance with the respective requirements. Each of these options is available with independent sensors and upon request, with the control loop sensors.

  • Pharma software package complying with FDA 21 CFR part 11 for conneting devices and test chambers to aPC.
  • Additional, any existing temperature or climate devices can be connected to independent computers using our Pharma software which complies with FDA 21 CFR part 11.

 

Qualification

Approval of active substances and/or providing evidence of stability tests requires numerous measurements that have to carried out and confirm over extremely long period of time. To provide evidence of compliance with fluctuations in temperature and humidity, it is neccessary to ensure the flawless functioning of stability test chambers. These requirements are documented in sustainable manner by means of our extensive qualification documentation.

The qualification system is comprised of:

  • Calibration certificates
  • Design Qualification
  • Installation
  • Operation qualification
  • Performance qualification

 

In addition to this we provide all the required documents such as circuit diagrams, component lists and certificates.

 

Calibration

Various quality assurance systems require calibration and monitoring of test equipment that can be traced back to standards which are approved nationally. Provides calibration and calibration certificates for the measurable variables of air temperature and relative humidity. Our trained calibration technicians can perform calibrations and spatial measurements of temperature and humidity both in our factory as well as on site

 

Application

When testing the stability of drugs according to the ICH guidelines, products must be stored under defined climatic conditions. The functionality of the cabinets satisfies the basic requirements of the official guidelines as well as the demands of special application.

 

Standard Equipment
  • PLC based control
  • Serial interface RS 232
  • Humidity input and display in % relative humidity
  • I n dependent adjustable température limiter t min / t max
  • Calibration of temperature and humidity values with certificate
  • Air-cooled refrigeration unit
  • Stainless steel interior
  • Door switch
  • Single door with lock facility
  • Mobile on rolling wheels
  • Shelves (depending on workspace volume)
  • mported Humidification
  • System

 

Important Options
  • Colour touch screen
  • Pharma software
  • Networking (RS 485 interface)
  • I ndependent sensor for temperature and humidity
  • Audible and visual warning signal
  • Additional shelves
  • Additional entry ports
  • Qualification documentation
  • Special voltage
  • Standby refrigeration system
  • Password system for door

 

Other products
  • Walk In Cold Storages
  • Walk In Cold Storage with Deep Freezer
  • Cooling Incubators
  • Photo stability Chambers
  • BOD Incubators
  • Stability Ovens
  • Deep Freezers
  • Bacteriological Incubators
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