Pharma Testing Equipments

Leveraging on our skilled pool of industry professionals, we are involved in the manufacturing, supplying and exporting Walk-in Stability Chambers. Highly reliable, these stability chambers are pretested in the prevailing industry standards. These chambers are used for passing FDA and ICH Q1A compliance standards. But these could exceed these guidelines for long term, intermediate and accelerated stability studies.

Application Area:

• Used in the big industries
• Used for passing FDA and ICH Q1A compliance standards

Features:

• Designed to be used for long period of time
• Splendid functionality
• In built over load protector provided for hermetically sealed compressor

• Capacity : 2000 Litre to 1 Lac Litre
• Temperature Range: 20 °C to 60 °C
• Accuracy: ± 0.2 °C
• Temperature uniformity: ± 2 °C.
• Humidity Range: 40% to 95%
• Accuracy: ± 2% RH
• Humidity Uniformity: ± 3% RH
• Power supply: 1 Phase, 230 V ± 10% AC, 50 Hz. OR 3 Phase, 440 V

Wadegati offers a wide range of stability testing chambers that satisfy ICH Q1B guidelines. A state of the art Photostability chambers are available. This chamber has the capability to provide fluorescent light intensities from 1,000 to 10,000 Lux hour. Samples stored at 10,000 Lux can satisfy the ICH guidelines for light exposure in as little as five days. The UV study is done simultaneously. Separate switches are provided for incandescent & UV light sources.

The current ICH guidelines specify that drug and drug products must be phototested to ensure that exposure to light does not cause photochemical degradation of the product or packaging. The product under test must receive a measured dose of both UV-A (200 watt-hours per square meter) and visible (1.2 million lux-hours) optical radiation exposure. This requires both radiometric and photometric measurements in terms of illuminance in lux and UV-(315 to 400 nm) irradiance in W/m2 multiplied by exposure time in hours.

Storage Conditions

• 25°C Ambient Humidity.
• 30°C Ambient Humidity.
• Photostability…. 1,000 to 10,000 Lux (ICH Option 2).

Sequential and simultaneous ageing test. In addition to the temperature ageing, the short period photo-ageing is separately carried out with extremely strong light having a defined lighting specifications or the simultaneous ageing with temperature lighting in accordance with ICH guidelines.

• Construction as per cGMP regulations.
• Consisting of refrigeration, air handling, humidification, dehumidification,
  temperature/humidity controlling
• Microprocessor based 2 channel multifunctional PID Temperature / Humidity ( RH) controller for simultaneous control of temperature and % RH. OR PLC based system for chamber control and auto changeover of standby system
  with touch screen display.
• Printer interface & PC interface for data storage
• Standard networking via Ethernet.

Light sources option 2 :

1. UVA intensities = 1.5 w/m² (require about 133 hours)
2. VIS intensities = 10,000 lux (require 120 hours)

Validation :
DQ/ FAT /IQ / OQ / PQ documentation with test and calibration certificate.

Safety Features :

• Special software incorporated in the controller to give ‘FAULT’ indication in case of failure of any control system.
• Audio alarm to signal variation in set temperature.
• A safety thermostat is provided to switch off the illumination if temperature overshoots.
• Door switch to switch off the UV light when door is opened.
• Safety digital temperature controller for main controller : In the event of failure of Micro- PID Controller the high accurate safety controller will take over temperature controlling.
• Over load Protector for compressor.

• For mixing, diffusion dialyzing, serological, VDRL tests, growth of culture/organisms, pathological work, blood grouping tests.
• Compact, durable, counterbalanced mechanism, ensuring reliability even in continuous use, unaffected by uneven load distributions.
• Electronic frequency control, steplessly adjustable, with gentle start-up, timed runs.
• 50 to 250 RPM with speed regulator and is indicated on digital display.
• Heavy duty DC motor with DC drive used to regulate the speed.
• Rotating platform is made of thick gauge stainless steel with clamp for holding the Erlen meyer flasks.
• Platform size : 300 x 300 mm.
• Orbit diameter : 25 mm.
• Capacity : For 12/16/24/36 or more flasks of 250 / 500 / 1000 ml.

• Double walled construction, both inner working chamber and outer made of stainless steel.
• High grade thermal insulation lagged in between the walls to prevent temperature loss.
• Immersion stainless steel heaters fitted.
• Fully automatic time proportional digital temperature controller with PT-100 sensor.
• Temperature range : Above ambient to 300°C.
• Capacity : 1 / 5 / 10 / 20 Litres

• Application ranges, closed monitoring of temperature and regulated shaking for laboratory research.
• Double walled Construction with regular and GMP models.
• Front opening door with double pane window on the door.
• Microprocessor based PID temperature controller with PT-100 sensor.
• Easily replaceable air tubular heater to heat the chamber.
• Dynamically balanced chamber circulatory system.
• A well balanced CFC-free refrigeration system with eco-friendly refrigerant.
• Shaking mechanism is driven by high torque DC motor.
• The speed of the rotating platform is continuously variable from 50 to 200 rpm and is indicated on digital display.
• Rotating platform and lotus clamps are made out of 304 AISI stainless steel.
• Capacity : For 16/24/36 or more flasks of 250 / 500 / 1000 ml.
• Temperature range : a) 5°C above ambient to +60°C ± 0.5°C.
  b) 5°C to +60°C ± 0.5°C.

• Ideal for wide range of incubating, tempering, thermal storage and drying application.
• Double walled Construction with regular and GMP models.
• Thermal insulation lagged in-between the walls to prevent loss of temperature.
• Ventilator is provided on top for exhaust.
• The door will be of flush type and will be provided with positive locking arrangement.
• Heavy duty capacitor run motor with blower circulation provided from bottom of the oven for air circulation inside the chamber.
• The heating elements are fitted at the bottom of the oven to facilitate uniform dissipation of heat all over the chamber.
• Digital temperature controller with Cr/Al thermocouple.
• Working size : 45 x 45 x 45 cms, 60 x 60 x 60 cms & 60 x 60 x 90 cms
• Temperature range : Above ambient to 250°C, 300°C & 400°C.

• Double walled Construction with regular and GMP models.
• Stainless steel cover with concentric rings.
• Temperature digitally controlled.
• Water immersion heaters.
• Working size : 14" x 10" x 4" Holes : 6 of 7.5 cms dia.
• Working size : 16" x 12" x 4" Holes : 12 of 7.5 cms dia

• Ideal for wide range of incubating, tempering, thermal storage and drying application of inflammable material.
• Triple walled construction with inner and middle chamber form a jacket and made out of thick gauge stainless steel.
• Water inlet / outlet and overflow provided.
• Stainless steel water reservoir with float valve is fitted on the rear side of the oven.
• Thermal insulation lagged in-between the walls.
• The door will be of flush type and will be provided with positive locking arrangement.
• Heavy duty flameproof motor having class "F" insulation and IP-55 protection with blower provided on top of the oven for air circulation inside the chamber.
• Flameproof heating elements are wound around the chamber to facilitate uniform dissipation of heat all over the chamber.
• Flameproof, weatherproof enclosed Digital temperature controller with PT-100 sensor.
• Working size : 45 x 45 x 45 cms.
• Temperature range : Above ambient to 80°C.

• Circulatory water bath with microprocessor based programmable PID controller with PC interface.
• Capacity : 5 Litters glass beaker with thermo stirrer driven by DC motor with Variable speed regulator and digital rpm indicator.
• Cooling coil with inlet & outlet is provided to bring down the temperature.
• Temperature range : Above ambient to 110°C.

BOD test chambers are especially built to pass FDA and ICH compliance standards and have a reputation for reliability, quality and performance.

1. Construction as per cGMP regulations.
2. Consisting of refrigeration, air handling, humidification, dehumidification, temperature/humidity controlling
3. Microprocessor based PID Temperature controller OR
   PLC based system for chamber control and auto changeover of standby system with touch screen display.
4. Printer interface & PC interface for data storage
5. Standard networking via Ethernet.

Data Acquisition system complying to US FDA 21 CFR Part 11

1. Data records & process control systems have Electronic Signature & Electronic Record capability. The controllers have a lockout feature that permits changes through a 21CFR Part11 compliant operator station, thus providing the necessary audit trail.
2. Mean Kinetic Temperature value.
3. Password security for log in and door operations.
4. Operators need to enter user name and password before taking any action.
5. Report search option using date and sample name.
6. Secure computer generated, time stamped runtime audit trail of batch stop/start, alarm acknowledgements, logins, signature details, configuration changes.
7. User actions with signing and authorization.
8. Access control according to authority level.
9. Export conversion facility to Excel.

Temperature Data Logger :
4 channel or 8 channel , calibrated data logger to print date, time, temperature set and process values for mapping and auto validation. Features like printer and PC interfacing provided.

Standby Systems:
Standby refrigeration and sensor

Mobile Alert :

1. Different Alarm indication through Mobile SMS Alert (from single to multi user)
2. Process value indication through Mobile SMS Alert(from single to multi user)

Validation :
DQ/ FAT /IQ / OQ / PQ documentation with test and calibration certificate.

Safety features :

1. Special software incorporated in the controller to give ‘FAULT’ indication in case of failure of any control system.
2. Audio alarm provided to signal variation in temperature.
3. Safety digital temperature controller for main controller : In the event of failure of Micro-PID Controller the high accurate safety controller will take over temperature controlling.
4. In built over load protector provided for hermetic sealed compressor.

• Application ranges, research and development laboratories of industry, medicine and biotechnology, incubation of valuable biological products, calibration tests and external circulation.
• The main reservoir is made of thick gauge S.S. with drain.
• The bath is having drop-in lid with handle.
• 'PUF' insulation lagged in between the walls to prevent temperature loss.
• A well balanced CFC-free refrigeration system with eco-friendly refrigerant.
• Stainless steel water immersion heaters.
• Thermo stirrer with centrifugal pump driven by heavy-duty capacitor run AC motor helps maintain uniform temperature across the bath media.
• Can be used for external tempering.
• Microprocessor based PID temperature controller with PT-100 sensor.
• T emperature range : +60°C to -80°C.
• Capacity : 5 / 10 / 15 / 20 Litres

• Water condensing based on refrigeration principle for positive control of humidity.
• Several manufacturing processes involving the production of pharmaceuticals, chemicals and foods, high cost sophisticated instrumentation room require an atmosphere of lower humidity.
• Low humidity is also imperative in packaging room, food grains and seeds storage rooms and also in warehouses where hygroscopic materials are stored.
• The equipment is based on refrigeration principle and removes the moisture content of humid air in an enclosed room and condenses the moisture of the humid air into water continuously which drops into a tray.
• Both heat exchanger and water condensing coils are of high transfer efficiency.
• TEFC fan cooled single shaft motor fitted with forward curved centrifugal fan.
• Capacity : 1.0 Ton suitable for room volume of 2250 CU.FT.
  1.5 Tons suitable for room volume of 3500 CU.FT.
  2.0 Tons suitable for room volume of 3900 CU.FT.

• Application ranges, storage and preservation of valuable biological products, enzymes, virus, serum, blood plasma, heat sensitive vaccines, insulin, lever extract, medicines.
• Double walled Construction with regular and GMP models.
• 'PUF' insulation lagged in-between the walls to prevent loss of temperature.
• A well balanced CFC-free refrigeration system with eco-friendly refrigerant.
• Microprocessor based PID temperature controller with audio-visual alarm for variation in temperature incorporated.
• Temperature : Down to -86°C.
• Capacity : 100 / 200 / 300 / 400 / 500 / 800 / 1000 Litres

• Ideally meets the high demands made in biology, research, industry and medicine.
• Very easy and convenient handling, progressive technology, high reliability and long service life are the main features of these centrifuges.
• Flameproof / non flameproof version for solid to liquid separation.
• Perforated basket made of stainless steel 316 casting dynamically balanced.
• Collecting tank made of 316 stainless steel with drain pipe.
• Lid with continuous feeding provision.
• Capacity : 1 / 2 / 5 / 10 Litres

• Plant Growth chambers are designed to facilitate many botanical and agricultural research applications, including seed germination studies, plant pathology, plant tissue culture studies and plant genetic research.
• Double walled Construction with regular and GMP models.
• 80mm thick 'PUF' insulation lagged in-between the walls to prevent loss of temperature.
• The chamber has two doors, inner full view glass door and outer metallic door with positive locking.
• A well balanced CFC-free refrigeration system with eco-friendly refrigerant.
• Easily replaceable air tubular heater to heat the chamber.
• Dynamically balanced chamber circulatory system.
• Incorporated with microprocessor based programmable PID temperature / humidity control system for accurate control of humidity.
• Temperature and % of RH are displayed on digital meter.
• Programmable timer for regulating day / night effect.
• T emperature range : 10°C to 50°C, ± 0.5°C.
• Humidity range : 40% to 95% + 2% RH.
• Light level : 2,000 TO 16,000 lux
• Capacity : 200 / 400 / 800 / 1000 Litres

Pharma Chambers are especially built to pass FDA and ICH compliance standards and have a reputation for reliability, quality and performance.

• Construction as per cGMP regulations.
• Consisting of refrigeration, air handling, humidification, dehumidification, temperature/humidity controlling
• Microprocessor based PID Temperature controller OR
  PLC based system for chamber control and auto changeover of standby system with touch screen display.
• Printer interface & PC interface for data storage
• Standard networking via Ethernet.

Data Acquisition system complying to US FDA 21 CFR Part 11

1. Data records & process control systems have Electronic Signature & Electronic Record capability. The controllers have a lockout feature that permits changes through a 21CFR Part11 compliant operator station, thus providing the necessary audit trail.
2. Mean Kinetic Temperature value.
3. Password security for log in and door operations.
4. Operators need to enter user name and password before taking any action.
5. Report search option using date and sample name.
6. Secure computer generated, time stamped runtime audit trail of batch stop/start, alarm acknowledgements, logins, signature details, configuration changes.
7. User actions with signing and authorization.
8. Access control according to authority level.
9. Export conversion facility to Excel.

Temperature Data Logger :
4 channel or 8 channel , calibrated data logger to print date, time, temperature set and process values for mapping and auto validation. Features like printer and PC interfacing provided.

Standby Systems:
Standby refrigeration and sensor

Mobile Alert :

1. Different Alarm indication through Mobile SMS Alert
   (from single to multi user)
2. Process value indication through Mobile SMS Alert
   (from single to multi user)

Validation :
DQ/ FAT /IQ / OQ / PQ documentation with test and calibration certificate.

Safety features :

1. Special software incorporated in the controller to give ‘FAULT’ indication in case of failure of any control system.
2. Audio alarm provided to signal variation in temperature.
3. Safety digital temperature controller for main controller : In the event of failure of Micro-PID Controller the high accurate safety controller will take over temperature controlling.
4. In built over load protector provided for hermetic sealed compressor.