Environmental Chamber. Stability/ GMP 2000 Series. Stability Testing Chambers

Transcription

1 GMP 2000 Series ISO 9001: CFR PART 11 COMPLIANCE SOFTWARE Stability/ Environmental Chamber Stability Testing Chambers Walk-in Test Chambers for Stability Tests on Pharmaceutical Products according to the ICH and FDA Guidelines

2 Assuring the Quality THE COMPANY GMP Technical Solutions is an ISO manufacturing equipments GMP can be incorporated into a proposed Certified company and is houses its own epoxy polyester design product requirement one of the largest manufactures of powder coating wet coating plant Demountable Partitioning Systems and PUF machines for cold room The capacity of the manufacturing Clean Room Doors Fire Doors panels facility results in timely delivery and Storage Racks Clean Room prompt technical support is provided Equipments Stability Chambers The strategic location of the facility at by a network of skilled technical Cold Storages Environmental the foothills of Himachal Pradesh persons across India and abroad Chambers Laboratory Ovens Dual offers ZERO Excises Duty This Chambers BOD Incubators benefits our clients and enables GMP The in-house testing facility with Incubators Refrigerators Deep to offer a competitive pricing structure modern test equipments ensures Freezers in the Indian subcontinent e q u i p m e n t ' s p e r f o r m a n c e The latest state of the art machineries compliance with the relevant GMP was established in under for cutting bending punching regulatory requirements. Our team of the Indian Companies Act and ensures International product quality highly trained engineers provides commenced production on st and high quality engineered product installation validation after sale October GMP Technical service support including important Solutions has an 1,20 sq ft All GMP products are manufactured test and calibration documentation manufacturing area with an overall under one roof and subsequently all supportive infrastructural area of metal finishes assembly are sq ft which is fully completed in house As a result equipped with the latest CNC NC specific requirements of our Clients 1

3 Ensuring Confidence 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 25?C / 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 semipermiable packing: Climate Test Chambers with Optimized Storage Areas for Reliable Stability Testing of Pharmaceuticals Long-term testing At 25?C / 40% RH Accelerated testing At 40?C / <25% RH During the entire test, the deviation in o temperature is stipulated at ±2 C and the deviation in relative humidity is stipulated at ±5%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. 2

4 Attention to Every Detail Product 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 connecting devices and test chambers to a PC. Additional, any existing temperature or climate devices can be connected to independent recorders or 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 necessary to ensure the flawless functioning of stability test chambers. These requirements are documented in a sustainable manner by means of our extensive qualification documentation. The qualification system is comprised of: Calibration certificates Design qualification Installation qualification Operation qualification Performance qualification In addition to this we provide all the required documents such as circuit diagrams, component lists and certificates. 3

5 Tailored to your Requirements 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. Standard Equipment PLC based control Serial interface RS 232 Humidity input and display in % relative humidity Independent 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) Imported Humidification System Important Options Colour touch screen Pharma software Networking (RS 485 interface) Independent 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 ISO 9001:2000 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. 4

6 Other products Walk In Cold Storages Cooling Incubators BOD Incubators Deep Freezers Walk In Cold Storage with Deep Freezer Photo stability Chambers Stability Ovens Bacteriological Incubators ISO 9001:2000 Registered Office GMP Technical Solutions Private Limited rd floor Swastik Disha Business Park Behind Wadhani Industrial Estate L B S Marg Ghatkopar W Mumbai Maharashtra India Tel Fax E mail enquiry gmptech net Website www gmptech net www gmpartitions com Noida Office RS Second floor Savitri Market Sector Noida U P Tel Fax E mail salesdelhi gmptech net Works Gunai Road Mandhala Via Barotiwala Distt Solan Himachal Pradesh India Tel Fax, Mob E mail sales gmptech net Website www gmptech net www gmpartitions com