WADEGATI
LABEQUIP PVT. LTD.

®

Pharmaceutical Equipments

Petroleum Testing Equipment

Grease Industry

Electrical, Electronic and
Automobile Industry

Soap and Detergent Industry

Lab Model
Walk-in Type

• Walk-in Stability test chambers are especially designed to carry out stability and shelf life test on drug and drugs substance according to ICH / FDA / WHO guidelines.
• D ouble walled Construction with regular and GMP models.
• P re-engineered, Pre-fabricated modular panels with 80mm thick 'PUF' insulation with easy-to-assemble panels on site.
• Inside coating of floor is of either aluminium or stainless steel sheet 10 SWG thick, pressed , non-slip.
• Perfect insulation and minimum power consumption.
• Fastenings are cam locks for easy assembly and possible disassembly.
• T he door has two pane toughened glass viewing windows.
• Stainless steel racks and perforated trays to utilise the chamber for its maximum capacity.
• A port hole of 50mm dia is provided on the side wall for inserting calibration transmitter.
• A well balanced CFC-free bypass ducting refrigeration system with eco-friendly refrigerant.
• Easily replaceable air tubular heater to heat the chamber.
• Low pressure water boiler & water reservoir with float valve & water level switch.
• Non-condensing water vapours injected into the chamber for humidification.
• Dynamically balanced chamber circulatory system.
• Microprocessor based 2 channel multifunctional PID Temperature / Humidity (RH) controller used for processes requiring simultaneous control of temperature and % RH with capacitor type RH transmitter as RH sensor.
• The controller provides independent control output in the form of DC pulses for external solid state relays to control air heater, compressor and boiler heater.
• Separate display for Temperature, Humidity Set point and process value & real time clock.
• Easy front panel keyboard programmable.
• T emperature range : 20°C to 60°C, ± 2°C.
• Humidity range :         40% to 95% ± 3-5% RH.
• Capacity :                     8000 / 13000 / 15500 & 18000 Litres

Data acquisition system complying to 21 CFR Part 11

• 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.
• Validating products to GAMP guidelines.
• Recorded files are in binary, compressed and checksumed format.
• Protection of records to enable their accurate and ready retrieval.
• Each user can have individual password protected user accounts.
• Secure computer generated, time stamped runtime audit trail of batch stop/start, alarm acknowledgements, logins, signature details, configuration changes.
• Multi batch recording.
• Standard networking via Ethernet.
• Report generation via Excel Add-in option.

Tamperproof Electronic Records

• Process Values and Audit Trails. (Alarms, Events, Electronic Signatures)
• Date and Time stamped.
• Time Synchronisation.
• Viewable in human readable format.
• Export conversion facility to Excel.

Electronic Signature

• User actions with signing and authorization.
• Unique signatures required.
• Automatic Log-off.
• Minimum length password.
• Access control according to authority level.

Validation Services Include

• Feasibility study.
• User requirement specification assistance.
• Hosting of supplier audit.
• Fully documented project implementation to GAMP life cycle model.
• Commissioning assistance.
• IQ, OQ , PQ assistance.
• Ongoing operational support with service level agreement.
• GAMP Validation Templates CD
     Functional Specification
     Test Specification
     Test Result Sheets

Service Support

Request Demo

E-mail