Fitoclima Pharma. Stability and Photostability Chambers for the pharmaceutical industry

Transcription

1 Fitoclima Pharma Stability and Photostability Chambers for the pharmaceutical industry Compliance with ICH Q1A [Stability] and ICH Q1B [Photostability] Data logging in compliance with FDA 21 CFR Part 11

2 Designed in accordance with all requirements of the International Conference on Harmonization (ICH), these chambers are intended for stability (Q1A) and photostability (Q1B) testing in pharmaceutical products. With volumes from 600 liters to walk-in test chambers, the Fitoclima Pharma range stands out for its precision, stability and uniformity of all climatic conditions. Designed to provide durability, flexibility and ease of use, the Fitoclima Pharma chambers are the latest and smartest solutions to all pharmaceutical testing requirements. Compliance with ICH climatic conditions: 25ºC ± 2ºC; 40%RH ± 5%RH 25ºC ± 2ºC; 60%RH ± 5%RH 30ºC ± 2ºC; 65%RH ± 5%RH 30ºC ± 2ºC; 75%RH ± 5%RH 40ºC ± 2ºC; 75%RH ± 5%RH Key Features: The most advanced technology in climate control with ultrasonic generator and capacitive sensor Internal aerodynamic optimization to ensure uniformity of climatic conditions Nonpolluting construction and cooling system Quiet functioning Equipped with digital CLIMAPLUS 500 controller with customizable alarms and software for data monitoring and recording in accordance with FDA 21 CFR Part.11 Reduced investment, low maintenance, reliable and accurate performance Compliant with international standards and requirements ICH, DIN, EN, IEC, ISO, NP and UNE Fitoclima Pharma

3 ICH Q1A - Chambers for Stability Tests Temperature range Technical Specifications FITOCLIMA S600 Pharma 0ºC to +45ºC (range upgradable up to +60 ºC) Precision ± 0,5 ºC Fluctuation ± 0,5 ºC Uniformity ± 1,0 ºC Humidity Range Display resolution Precision Fluctuation Uniformity Shelves Volume Electrical Supply 35% to 95% RH 0,1 % RH ± 1 % RH ± 2 % RH ± 2 % RH 4 shelves with 530 x 640 mm (1,3m²) 600 liters 1/N/PE AC 230V ± 10%; 50Hz Temperature range Technical Specifications FITOCLIMA D1200 Pharma 0ºC to +45ºC (range upgradable up to +60 ºC) Precision ± 0,5 ºC Fluctuation ± 0,5 ºC Uniformity ± 1,0 ºC Humidity Range Display resolution Precision Fluctuation Uniformity Shelves Volume Electrical Supply 35% to 95% RH 0,1 % RH ± 1 % RH ± 2 % RH ± 2 % RH 8 shelves with 530 x 640 mm (2,6m²) liters 1/N/PE AC 230V ± 10%; 50H * Dimensions: Exterior Dimensions Interior Dimensions Model S600 D1200 S600 D1200 Width 730 mm mm 600 mm mm Depth 920 mm 810 mm 660 mm 660 mm Height mm mm mm mm (*) Other sizes available, including walk-in models

4 ICH Q1B - Chamber for Photostability Tests Fitoclima S 600 PLH Pharma This chamber is designed to simulate and automatically reproduce the conditions required by the Guideline ICH Q1B Option 2. Each radiation spectrum is independently controlled and can be programmed by % or intensity, and is measured by radiometers for visible or near UV according to traceability standards. Each type of radiation has a sample placement area of 0.7 square meters spread over two shelves. Optional nm and UV nm radiation sensors can be added to each shelve. FDA CFR part 11 FitoLog and FitoView software enable complete data logging of radiation, temperature and humidity information. Programming radiation and exposure times is made independently for visible light and UV radiation directly at the chamber with the CLIMAPLUS 500 controller. All accessories for the photo stability tests can be easily removed from the chamber, which then may be used for stability testing in any other ICH climatic conditions. ICH Q1B - Photostability Testing S600 & 1200 PLH Pharma VIS lamp type 8 fluorescent HF cool white lamps VIS light Intensity 3 to lux UVA lamp type 8 fluorescent HF near UV lamps UVA light Intensity 3 to 30 W/m 2 Uniformity ± 5 % Intensity control Independent VIS and UVA radiometers ICH VIS recommendation 1.2 MM lux / hour = 40 hours ICH UVA recommendation 200 W/m 2 = 7 hours ClimaPlus controller specific for the Photostability (ICH Q1B) chambers with automatic integration of VIS and UV detectors and radiometer

5 Fitoclima S600 and 1200 Pharma (stability) Interior view of 600 Pharma Q1B Technical description, Software and Accessories: Technical description: Monobloc design, with polyurethane insulation and stainless steel interior and exterior. Front panel with Zincor steel and gray epoxy paint Pivoting door with spring lock, magnetic gasket and safety lock 4 or 6 casters with built in brakes ClimaPlus 500 controller for data logging Audio and visual alarm system Open door alarm Free slot for remote alarm configuration B class PT100 stainless steel temperature sensor Electronic capacitive humidity sensor Low-noise, air based, CFC free mechanical refrigeration by sealed condenser group Humidification by ultrasonic generator with automatic level control and self-cleaning function Dehumidification by condensation of the cooling system evaporator Heating by stainless steel electric resistors Thermal safety with maximum and minimum temperature limits controlled by independent thermostats with incorporated alarms Air-flow forced by sealed fans with electronic switching Air renewal through adjustable breathing holes Automatic stop when opening doors RS232/485 Interface FitoLog400R Software 50mm diameter side port Mains switch

6 Controller Home The Fitoclima Pharma stability chambers are equipped with the ClimaPlus touch-screen controller with dual microprocessor technology for controlling, monitoring and registering all operating data. Programmable PLC ClimaPlus developed for the pharmaceutical industry Non-volatile memory 0,1ºC temperature resolution 0,1% HR humidity resolution Managing and monitoring alarms Possibility of integrating external commands and devices with ClimaPlus controller Different outputs for connecting devices Password protection of controller functions Software The FitoLog 400R software is a set of applications designed to monitor and register data from the chambers processes variables for the pharmaceutical industry and in accordance with the FDA 21 CFR Part.11 Guideline. The software consists of 3 applications: FitoLog, FitoView and FitoProgram. FitoLog FitoView FitoLog: Displays and records in real time all data and details of the measures and respective set-points in a file, with a pre-determined time interval. It also acquires the data of process variables, errors, alarms and allows external alerts configurations which may include or SMS to report the condition of the equipment or warning of alarm conditions. FitoView: It is a working tool to process the data acquired by FitoLog. You can view, print and export to other file types, and analyze the data in other programs (Excel, Access or others). FitoProgram: This application allows the designing of test programs and its integration on the chamber controller.

7 Radiation Calibration for photostability chambers In addition to the calibration of each fixed radiometer provided with the equipment, each photostability Fitoclima Pharma chamber is pre-calibrated by comparison with a standard radiometer, certified annually by an accredited lab. Optional Accessories Software FitoLog Pharma, FDA 21 CRF Part 11 compliant Light and UV sensors ( nm and UV nm) configurable and with integrated full data logging on the ClimaPlus 500 controller (ICH Q1B Option 2) IQ, OQ, PQ qualification and documentation for equipment and software H2O demineralizer Conductivity device and connection accessories for water quality control Aquarec s water recirculation and purification system Double glass see-trough doors

8 Installation Requirements To assure a correct functioning of the chamber, the following installation conditions are required: Installation site The place should be easily accessible, according to equipment dimensions and weight. It should have good air circulation and a room temperature between 10º and 26ºC. The floor should be leveled and a minimum distance of 50cm from the walls of other equipment must be kept. Electrical supply Near the equipment with the specified requirements. Humidification circuit and demineralized water (for models with Humidity) The humidification circuit works exclusively with distilled or demineralized water. For this circuit, a water admission pressure of 1 to 6 bares and conductivity of 5μ Siemens is required. Drain At floor level and near the equipment. The draining of the humidification and cooling systems water is done by gravity. For a correct draining there should be a minimum inclination of 10º in a descending trajectory from the chambers draining pipe until the sewage system. Equipamentos de Laboratório e Electromecânica Geral, Lda. Av. de Santa Isabel, nº 7, Albarraque Rio de Mouro Tel.: Fax: aralab@aralab.pt URL: