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Product List                                                                         Walk-in- Humidity Chamber            ...
About Mackpharmatech                                                              Founded in 1999 by a group of visionary ...
Our Commitment                                                                                                            ...
Documentation                                                                                         Pre - Requirements  ...
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  1. 1. Product List Walk-in- Humidity Chamber Walk-in- Cold Chamber Walk-in - Incubator Humidity Chamber Photostability Chamber B.O.D. Incubator Deep Freezer (up to -60°C) Cold Chamber (2°C to 8°C) Refrigerator Dual Zone Chamber Bacteriological Incubator Seed Germinator ADDRESS: Laboratory Oven Hot Air Oven Mack Pharmatech Pvt. Ltd. B-48, Malegaon MIDC, Low Temperature Water Bath Constant Temperature Water Bath Sinnar, Dist.-Nasik, Vacuum Oven Muffle Furnace (up to 1100°C) Pin- 422 113, Maharashtra, INDIA. AMC: We also undertake AMC and Calibration of equipment. TELEFAX: +91.2551.230877 URL: Sales Off.: Delhi Hyderabad Nasik Gujarat Service Center: EMAIL: Mumbai Bangalore Delhi Hyderabad Pune Visakhapatnam Gujarat Corporate OfficeManufacturing Unit A Matchless Solution for Environmental Testing Our Clients w w w . m a c k p h a r m a t e c h . c o m Note: In line our corporate policy of continuing product improvement and quality control, MACK PHARMATECH reserves the right to change product specification without notice. REVISED EDITION: 02 | Aug. 2011
  2. 2. About Mackpharmatech Founded in 1999 by a group of visionary professionals MACK PHARMATECH is a vision translated into reality. Founders experience, expertise and vision in the field of pharmaceutical equipment rendered MACK PHARMATECH to be the youngest face to emboss the mark in India and abroad. MACK PHARMATECHs identity is EnvironmentalSuccess Testing Equipment for Pharma and Laboratory with durability & quality, yet cost effective. MACK PHARMATECHs backbone for the quality manufacturing is the perfectMACK PHARMATECHs success lies in Quality and amalgamation of robust in-house Engineering along with ceaseless R&D. Its mainCustomer Service. MACK PHARMATECH keeps identity strength lies in its flexibility, adaptability, keen to the changing environment and acutefocus firmly on ceaseless R&D and manufacturing projection of forth coming scenario. Hence it results swiftness in developing newquality product with international standards. We offer products. The company is always focused on designing and manufacturing high quality and cost effective Environmental Testing equipment for Pharma and Laboratory.the equipment with the best quality, yet cost-effectiveresulting nonstop increase in the list of satisfied We are an ISO 9001:2000 organization certified by INTERTEK for the scope ofcustomer for the past 13 years. Technology has been Manufacture, Installation, and Servicing of Laboratory ahead and consequently we have been equippingand hiring service engineers with in-depth knowledge We manufacture all our products in accordance with GMP guidelines.and a greater range of skills than ever before so that they We add one more feather in our cap by being the first company in India to provide CEcan competently maintain todays sophisticated certified lab equipment. Our machines are CE approved and the components used aresystems. Compliant to European Standards. MACK PHARMATECH has met with all directives like:Attention to training endorses our commitment to Machine Directives 98/37/EEC.service. Our engineers receive regular external training Low Voltage Directives 73/23/EEC.on new equipment. Support from in-house personnel Electromagnetic Compatibility 89/336/EEC which are applicable for the equipment.with expertise in electronics, electrical and mechanicalengineering, together with technical assistance from We also have done the LVD, EMI/EMC tests by INTERTEK testing Services – ETL SEMCO, which is a European Notified Body and also accredited by NABL for testing services. Weour calibration department ensure that our engineers care for our customers and hence have taken care of not only quality product but alsohave the ability to provide a professional maintenance human and environment safety which are mandatory for CE approval.and breakdown service for all types of plant andenvironmental test equipment. Companys set of five core values: Integrity, Understanding, Excellence, unity, and Responsibility. These values have been part of our companys beliefs and convictions, from its earliest day, and these values continue to guide and drive our business decision. We continue to acquire and develop core technologies through rigorous R&D and through alliances with renowned suppliers and partners. Mack Pharmatech: Devoted to Excellence, Care and Safety. w w w . m a c k p h a r m a t e c h . c o m
  3. 3. Our Commitment MACK PHARMATECH is committed to be indispensable and the matchless solution for Common Features Environmental Testing, hence we must, as a team, remain hyper-sensitive to the changes for acute projection and continuously improve our professional knowledge and skills. KIRAN BADGUJAR Managing Director Control System PLC based control system with high usage data storage facility (250 Line) which gives accurate readings of temperature & humidity. 0.1°C Resolution for temperature & 0.1% Resolution for RH High stability & reliability, Security lock for prevention of unauthorized tampering, Non Volatile memory.Scanner Heating System Our commitment always ensures; our products are in compliance with GMP and otherFor Validation purpose Temp / Humidity multipoint Scanner can be High efficiency, low watt density S.S .tubular air heaters are used with ceramic core. The manufacturing regulations, on time delivery without any compromise in quality and 24X7 service backupprovided with printer & PC interface facility. combination of air flow, instrument response & fast reacting heaters provides very accurate & for proper maintenance service of our products through experts and expertise in electronics and straight line control of temperature. These heaters have a long life & are very reliable with no mechanical engineering.21 CFR PART-11 Compliance down timeLog data, Event data, Audit Trail data, E-Records & E-signatures, MANOJ CHAUDHARIGraphical analysis & Data acquisition. In-House Refrigeration System Director A single stage refrigeration system with a hermetically sealed reciprocating compressor. Fin &SMS Mobile Alert System tube type bullet expanded evaporator are used. High efficiency fin & tube type bullet expanded condenser coils are used. Refrigeration design protects compressors & prolongs life keepingWith GSM technology we will get malfunction SMS of equipment cool during all operating condition. Refrigeration design uses less power saving operating cost.on Mobile Phones. Humidity SystemInsulation Humidity is generated by water evaporation in separate compartment providing a water dropletEco Friendly Poly Urethane insulation provided maximum for free atmosphere, This ensures excellent uniformity & stability of the chamber environment .Athermal protection & to increase rigidity for reliable daily use. reservoir water tank is provided which is fitted with float valve to maintain the water level in the steam generator tank. Our MissionAir Circulation To exceed customer expectation by delivering the Best Quality Product with Quality-Swift-Service. Stand by Refrigeration & Humidity SystemA high efficiency air circulation system is an integral part of Two steam generators and two water reserve tanks are provided. In case of any system failure To adopt and devise advanced manufacturing techniques for ceaseless enhancement in qualitychamber construction This direct drive design has an extended or breakdown the stand by system is switched over automatically without disturbing the test and improvement in delivery performanceshaft electric motor coupled to aluminum centrifugal blower condition. To supply technologically advanced product and to bid 24X7 service.wheel. This horizontal airflow across the chamber working spaceis provides an even & accurate temperature & humidity gradient Safety System PLC based Safety controller is provided having eight safety cut-off with Auto reset facility.Interior Lighting Lower 1 Temp cut-off (Below set point): Cut off Refrigeration system with audio visualHigh intensity, low voltage fluorescent lights are provided. Interior indication.light makes viewing workspace & product hassle free. Our Vision Lower 2 Temp cut-off (Below set point): Cut off Load supply with audio visual indication To be the leading manufacturer of Environmental Testing EquipmentChamber Port60mm diameter port with silicon cork is included for passing Higher 1Temp cut-off (Above set point): Cut off Heating and Humidity system with audio visualsensor probes into the chamber workspace for validation without indication.altering the chamber.. Higher 2 Temp cut-off (Above set point): Cut off Load supply with audio visual indication. Lower 1 Humidity cut off (Below set point): audio visual indication Higher 1 Humidity cut off (Above set point): audio visual indication Our Values Higher 2 Humidity cut off (Above set point): Cut off Steam generator system with audio visual Customers are our highest priority since they are the cause and inspiration of the products. indication Customers feedback is highly valuable since it leads to innovation & perfection. Steam Generator Safety: Low water level cut-off, when water is not present in the steam generator tank. Exceeding customers expectations is the way to be on the top. We do business with integrity. Play to the strength and analyze the weakness.
  4. 4. Documentation Pre - Requirements MACK PHARMATECH provides full service validation of your equipment For Equipment including the following: Design Qualification (DQ): defines the functional and operational requirement and Description Required for InstallationCalibration: specification of the equipment and gives the conscious decisions in the selection of the Area Clean & free from dustCalibration is the comparison of an instrument to a known supplier. Surrounding Temp 20°C ~ 35°C (Recommended using AC)standard. Our equipment is calibrated with multipoint Level Horizontally leveledcalibrator, which is certified by ERTL (Indian Government Installation Qualification (IQ): confirms that all the equipment are installed to specifications. Right & Left Side Minimum 500mmAgency) traceable to NABL India and NPL (National Physical All of the model and serial numbers are documented. Back Side Minimum 500mmLaboratory), Delhi – the paperwork shows & compares Clearance Spacecorrectly to a chain of standards going back to a master Operational Qualification (OQ): verification of operator controls, alarms, software, stand by Top Side Minimum 500mm system, chamber temperature mapping and verification that chamber stays within the Door Open Area Greater than doors width size of equipmentstandard. humidity tolerances. Stability door entrance door Room door opening area should be greater than equipment sizeValidation: Distance between equipment and compressor unit should not exceed 45 feet Performance Qualification (PQ): confirms that the chambers are meeting the operating setValidation of equipment means preparing an authentic report Split type refrigeration unit (compressor unit) 3” diameter hole required at wall for passing copper pipe of split type refrigeration unit. points at stipulated product load. The temperature and humidity accuracy are also confirmed.of performance of the equipment, which establishes the Proper shade is required to protect compressor unit from rain water.fundamental documentary proof of proper working of the For non walk-in type Single phase, 230±10 VAC, 50 Hz, 20 Amp Required stabilized powerequipment within the specified limits of its performance, supply for equipment For walk-in type Three phase, 440±10 VAC, 50 Hz, 32 Ampaccuracy, and repeatability. Proper earthing Must For non walk-in type 3 core Cable specification For walk-in type 4 Core For non walk-in type 25 Amp Metal clad socket with MCB Pre - Requirements For DAAS Software For walk-in type 32 Amp / 63 Amp Required UPS for PLC & Control system Single phase, 230±10 VAC, 50 Hz, 250 VA Description Required for Installation Required stabilized power supply for Calibrator & Printer Single phase, 230±10 VAC, 50 Hz, 5 Amp Dual core, 2.3+ GHz processor Required LAN port [I/O] for communication of equipment and Information outlet [I/O] for each equipment and distance between equipment & port should not exceed L2 cache – minimum 2 MB software 2.5 meters. 3+ GB RAM Level Concealed (below ground level) Drainage CD-ROM (writer) Pipe specification 3” diameter PVC 160 GB HDD (SCSI) Water quality Dust free De mineralized or soft water Free LAN card Continuous water supply Pressure 1 kg/cm² ~ 1 Bar ~ 15 psi approx 1 LPT port to connect the printer Valve diameter ½ “ BSP PC Hardware & Software Free serial port RS 232 OR USB to RS 232 converter (for GSM) Dot matrix LX-300+ printer for taking print outs from calibrator and recorder Configuration for DAAS software For equipment Printer Interface & calibration print out Standard printer cable for Dot matrix LX-300+ printer with continuous stationary Free USB port – 2 nos. Operating system: MS Windows XP Professional version 2002 with service pack 2 installed. HP Laser Jet for taking print outs from computer with A4 size papers. Adobe Acrobat Reader – PDF Recommended Servo Voltage stabilizer MS-OFFICE 2003 with complete version [Excel, access, word] Distance between copper pipe of compressor unit & equipment should not exceed 45 feet Quick Heal Total Security [Note: Do not install any other Anti-Virus] Database software: MY-SQL 5.0 Java Runtime Environment JDK 1.5 TOMCAT 5.0 Web-server