TECHNICAL SPECIFICATION:
Temperature Range: 20°C - 60 °C
Humidity Range: 40%RH - 95%RH
Accuracy: ±0.2 °C / ± 2.0 % RH
Uniformity: ±1.0 °C / ± 3.0 % RH

Models	MK* -10H	MK* -20H	MK* -40H	MK* -60H	MK* -80H	MK* -100H
Features	100 Ltrs	200 Ltrs	400 Ltrs	600 Ltrs	800 Ltrs	1000 Ltrs
Interior Dimension
Width in mm	600	600	700	700	800	900
Depth in mm	350	400	600	800	800	850
Height in mm	550	850	950	1100	1250	1350
Exterior Dimension
Width in mm	700	700	800	800	1120	1220
Depth in mm	1020	1070	1270	1470	1470	1520
Height in mm	1415	1715	1815	1965	1850	1950
Trays
No of Trays	2	2	3	3	4	4
Type	Wiremesh type
Tray spacing	Every ½” Adjustable
Power supply	Single Phase, 230V 50Hz
Power Rating	2KW	2KW	3KW	3KW	4KW	4KW
Warranty	12 Months

OPTIONAL FEATURES:

21 CFR SOFTWARE PART 11 COMPLIANCE

STAND BY REFRIGERATION SYSTEM

STAND BY STEAM GENERATOR SYSTEM

SCANNER

EXTRA TRAY

TECHNICAL SPECIFICATION:
Temperature Range: 20°C - 60 °C
Humidity Range: 40%RH - 95%RH
Accuracy: ±0.2 °C / ± 2.0 % RH
Uniformity: ±1.0 °C / ± 3.0 % RH

Models	MK*- WH600	MK*- WH800	MK*- WH1200	MK*- WH1600	MK*- WH2400
Features	6000 Ltrs	8000 Ltrs	12000 Ltrs	16000 Ltrs	24000 Ltrs
Interior Dimension
Width in mm	2000	2000	2000	2000	4000
Depth in mm	1500	2000	3000	4000	3000
Height in mm	2000	2000	2000	2000	2000
Exterior Dimension
Width in mm	2160	2160	2160	2160	4160
Depth in mm	2250	2750	3750	4750	3750
Height in mm	2160	2160	2160	2160	2160
Racks & Trays
No of Racks	4	4	6	8	10
No of Trays	16	16	24	32	40
Tray size in mm	600 x 600	600 x 900	600 x 900	600 x 900	600 x 900
Type	Wiremesh type
Power supply	Three Phase , 440V 50Hz
Power Rating	7KW	8KW	8KW	9KW	15KW
Warranty	12 Months

OPTIONAL FEATURES:

21 CFR SOFTWARE PART 11 COMPLIANCE

STAND BY REFRIGERATION SYSTEM

STAND BY STEAM GENERATOR SYSTEM

SCANNER

EXTRA TRAY

TECHNICAL SPECIFICATION:
Temperature Range: 20 °C – 50 °C
Accuracy: ±0.2 °C
Uniformity: ±1.0 °C

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 comparison to be made between drug substance and drug product.

MACK PHARMATECH’s Photostability chambers are designed specifically to meet ICH & FDA requirements for Photostability testing. Near UV & visible light testing is performed simultaneously according to ICH Q1B option 2.

OPTIONAL FEATURES:

PRINTER INTERFACE FOR LUX & UV METER

AUTOMATIC SHUT OFF AFTER SPECIFIED EXPOSURE LEVEL.

Models	MK*- 10PH	MK*- 20PH
Features	100 Ltrs	200 Ltrs
Interior Dimension
Width in mm	700	700
Depth in mm	500	500
Height in mm	300	600
Exterior Dimension
Width in mm	1200	900
Depth in mm	600	1000
Height in mm	750	1450
Trays
No of Trays	1	2
Types	Perforated type
Power supply	Single Phase, 230V 50Hz
Power Rating	2KW	3KW
Warranty	12 Months

TECHNICAL SPECIFICATION:
Temperature Range: 2 °C – 8 °C
Accuracy: ±1.5 °C
Uniformity: ±2.0 °C

Models	MK*- 10CO	MK*- 20CO	MK*- 40CO	MK*- 60CO	MK*- 80CO	MK*- 100CO
Features	100 Ltrs	200 Ltrs	400 Ltrs	600 Ltrs	800 Ltrs	1000 Ltrs
Interior Dimension
Width in mm	600	600	700	700	800	900
Depth in mm	350	400	600	800	800	850
Height in mm	550	850	950	1100	1250	1350
Exterior Dimension
Width in mm	700	700	800	800	1120	1220
Depth in mm	830	880	1080	1280	1280	1330
Height in mm	1415	1715	1815	1965	1850	1950
Trays
No of Trays	2	2	3	3	4	4
Type	Wiremesh type
Tray spacing	Every ½” Adjustable
Power Supply	Single Phase, 230V 50Hz
Power Rating	1KW	1KW	1.5KW	1.5KW	2KW	2KW
Warranty	12 Months

OPTIONAL FEATURES:

21 CFR SOFTWARE PART 11 COMPLIANCE

STAND BY REFRIGERATION SYSTEM

SCANNER

EXTRA TRAY

TECHNICAL SPECIFICATION
Temperature Range: UPTO -30 °C
Accuracy: ±3 °C
Uniformity: ±3 °C

Models	MK*- 10DF	MK*- 20DF	MK*- 40DF	MK*- 60DF
Features	100 Ltrs	200 Ltrs	400 Ltrs	600 Ltrs
Interior Dimension
Width in mm	540	540	640	640
Depth in mm	350	500	650	750
Height in mm	550	750	1000	1250
Exterior Dimension
Width in mm	700	700	800	800
Depth in mm	605	755	905	1005
Height in mm	1195	1395	1745	1995
Trays
No of Trays	2	2	3	3
Type	Wiremesh Type
Tray spacing	Every ½” Adjustable
Power Supply	Single Phase , 230V 50Hz
Power Rating	1.5KW	1.5KW	2KW	2KW
Warranty	12 Months

OPTIONAL FEATURES:

21 CFR SOFTWARE PART 11 COMPLIANCE

EXTRA TRAY

TECHNICAL SPECIFICATION:
Temperature Range: 10 °C – 60 °C
Accuracy: ±0.2 °C
Uniformity: ±1.0 °C

Models	MK*-10BO	MK*-20BO	MK*-40BO	MK*-60BO	MK*-80BO	MK*-100BO
Features	100 Ltrs	200 Ltrs	400 Ltrs	600 Ltrs	800 Ltrs	1000 Ltrs
Interior Dimension
Width in mm	600	600	700	700	800	900
Depth in mm	350	400	600	800	800	850
Height in mm	550	850	950	1100	1250	1350
Exterior Dimension
Width in mm	700	700	800	800	1120	1220
Depth in mm	830	880	1080	1280	1280	1330
Height in mm	1415	1715	1815	1965	1850	1950
Trays
No. Of Trays	2	2	3	3	4	4
Type	Wiremesh type
Tray spacing	Every ½” Adjustable
Power supply	Single Phase, 230V 50Hz
Power Rating	1.5KW	1.5KW	2KW	2KW	3KW	3KW
Warranty	12 Months

OPTIONAL FEATURES:

21 CFR SOFTWARE PART 11 COMPLIANCE

STAND BY REFRIGERATION SYSTEM

SCANNER

EXTRA TRAY

21 CFR SOFTWARE PART 11 COMPLIANCE

• Secured audit trail (User, Equipment, Alarm SMS, Events).

• E-Records and E-Signatures with Date and Time stamp.

• MKT (Mean Kinetic Temperature).

• Unlimited equipments connectivity.

• Real time analysis.

• Graphical Analysis.

• First time user login change password.

• Password Encryption.

• Alpha numeric password and password ageing.

• System Administration.

• Authorized Multilevel Username and Password.

• Data Acquisition.

• Offline analysis (in Tabular and graphical analysis).

• Open door with reason master.

• Data generated on crystal report.

• Realtime parameter setting.

• SQL (RDBMS) database and Automated back up facility.

• Auto logout, account Blocking and reactivating facility.

• Log data, event and audit trail data recording.

• PLC based control system. PC communication via Ethernet.

• PLC based safety control to protect the chambers from overshoot and undershoot of Temperature and humidity.

• Auto changeover of master sensor in case of failure.

• Auto switch over of refrigeration system.

• Auto change over of steam generator.

• Online monitoring on Graphic LCD display.

• Alarm for low water level with reset system to protect steam generator system.

• Password protected door opening with reason master.

• Password protected chamber on / off.

• Snooze hooter system.

• Event logger facility.

• Password protected restore factory setting.

• Actual status monitoring of major utilities (Sensor, Ref System, Steam Generation).

• GSM alarm system (mobile alert).

Ethernet & GSM

With GSM technology we will get malfunction SMS of equipment on Mobile phones.

CALIBRATION:

Calibration 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.

VALIDATION:

Validation 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.


MACK PHARMATECH provides full service validation of your equipment including the following:

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 equipments are installed to specifications. All of the model and serial numbers are documented.

OPERATIONAL QUALIFICATION (OQ):
Verifies the operator controls, alarms, software, stand by system & chamber temperature mapping and verifies the 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 are also confirmed.