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Mack Pharmatech Pvt Ltd

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Our Products

  1. Laboratory Equipments 3 Products available
  2. Testing Equipments

    1 Products available
  3. Data Digitization

    1 Products available
  4. Measuring Instruments & Equipment

    1 Products available
  5. Cold Rooms

    1 Products available

Other Products / Services

Walk-in Chamber

  • Temperature Range 20°C - 60 °C
  • Humidity Range 40%RH - 95%RH
Stability Chambers are used in performing Stability Studies. Stability studies provide an evidence on the changes in the quality of product with Time, under the influence of varied environmental factors: Temperature, Humidity.Evaluation of product (API or Formulations) under recommended storage conditions, ( with appropriate tolerances) that test its Thermal Stability & if applicable, its sensitivity to moisture.
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Cold Chamber

  • Temperature Range 2° C to 8 °C
  • Accuracy +1.5 °C
  • Uniformity +2.0 °C

Features21 CFR PART-11 ComplianceLog data, Event data, Audit Trail data, E-Records &E-signatures, Graphical analysis & Data acquisition. Optional FeaturesSCANNERGSM TECHNOLOGYHOOTER SYSTEMEXTRA TRAY

Models MK*-20CO MK*-40CO MK*-60CO MK*-80CO MK*-100CO MK**-S100CO MK**-S200CO MK**-S300CO
Features 200 Ltrs 400 Ltrs 600 Ltrs 800 Ltrs 1000 Ltrs 1000 Ltrs 2000 Ltrs 3000 Ltrs
Interior Dimension                
Width in mm 600 700 700 700 800 800 1600 1900
Depth in mm 400 600 800 800 800 800 750 800
Height in mm 850 950 1100 1450 1600 1600 1700 2000
Exterior Dimension                
Width in mm 760 860 860 860 960 960 1940 2240
Depth in mm 865 1060 1265 1265 1265 1265 1110 1160
Height in mm 1450 1550 1700 2050 2200 2200 1890 2190
Trays                
No of Trays 2 3 3 4 4 4 8 12
Type Wiremesh Type
Tray spacing Every 1/2" Adjustable - -
Power Supply                
Power Supply Single Phase, 230V 50Hz
Power Rating 1KW 1.5KW 1.5KW 2KW 2KW 2KW 2.5KW 2.5KW
Warranty 12 Months
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Photostability Chamber

For confirmatory studies, samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours / square meter to allow direct comparisonto be made between drug substance & drug product. MACK PHARMATECHs Photostability Chambers are designed specifically to meet ICH & FDA requirements for Photostability testing. Near UV & visible light testing is Approved Approved performed simultaneously according to ICH Q1B option 2. Optional FeaturesGSM TECHNOLOGYHOOTER SYSTEM

Features
  • UV lights get switched off automatically once the door is opened.
  • You can test the samples on Fluorescent light or U .V lights separately as well as simultaneously.
  • Uniform light distribution & high intensity levels allow quick response for forced degradation testing and confirmatory studies.
  • Lights automatically shut off after a specified exposure level or time duration.
21 CFR PART-11 Compliance
Log data, Event data, Audit Trail data, E-Records &E-signatures, Graphical analysis & Data acquisition.

Models MK*-20PH MK*-40PH
Features 200 Ltrs 400 sLtrs
Interior Dimension    
Width in mm 800 800
Depth in mm 500 700
Height in mm 600 700
Exterior Dimension    
Width in mm 940 940
Depth in mm 960 1160
Height in mm 1175 1325
Trays    
No of Zones 1 2
Tray Perforated Type
Power Supply    
Power Supply Single Phase, 230V 50Hz
Power Rating 2KW 3KW
Warranty 12 Months
MK*-20PH MK*-40PH
200 Ltrs 400 sLtrs
   
800 800
500 700
600 700
   
940 940
1150 1350
1175 1325
   
1 2
Perforated Type
   
Single Phase, 230V 50Hz
2KW 3KW
12 Months

 

Models Material of Construction  
Interior Exterior
MK1 S.S.304 Mirror Finish G.I  Powder Coated
MK2 S.S.304 Mirror Finish S.S.304 Dull Finish
MK3 S.S.316 Mirror Finish S.S.304 Dull Finish
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Documentation

Design Qualification (DQ) Defines the functional and operational requirement and specification of the instrument and details the conscious decisions in the selection of the supplier. Installation Qualification (IQ) Confirms that all the equipment was installed to specifications. All of the model and serial numbers are documented. Operational Qualification OQ) Verification of operator controls, alarms, software, stand by system & chamber temperature mapping and verification that chamber stays within the humidity tolerances. Performance Qualification (PQ)Confirms that the chambers are meeting the operating set points at stipulated product load. The temperature and humidity accuracy is also confirmed.
Calibration & Validation
CalibrationCalibration is the comparison of an instrument to a known standard. Our equipments are calibrated with multipoint calibrator, which is certified by ERTL (Indian Government Agency) traceable to NABL India and NPL (National Physical Laboratory), Delhi one that has paperwork showing it compares correctly to a chain of standards going back to a master standard.
ValidationValidation of equipment means preparing an authentic report of performance of the equipment, which establishes the fundamental documentary proof of proper working of the equipment within the specified limits of its performance accuracy and repeatability.
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