Stability testing by definition is a long process. A stability test chamber must perform reliably and accurately throughout this time. Maintenance or service interventions during the testing are disruptive and costly. The Pharma-Safe system gives you long term, maintenance free, reliable and accurate performance.

All aspects of Pharma-Safe's design are totally compliant with ICH guidelines for stability testing (Q1A) and Photostability Testing (Q1B).

Cost of ownership has been minimised by the use of computer controlled refrigeration systems that actually control the flow of refrigerant gas levels rather than the conventional on/off systems. Water consumption is very low but with the AquaRec UV option it becomes negligible. In today's environment, conserving resources counts. Responsible design ensures low utilisation of valuable resources and minimises cost of ownership without compromising performance.

Validation procedures and documents have been developed and refined with input from leading global pharmaceutical companies. You can be confident that the Pharma-Safe validation protocols are recognised by industry leading organisations on every continent and will surpass even the most demanding requirements. Pharma-Safe is a global product for a global industry with personal localised service and support at its heart. Pharma-Safe dealers are trained and certified by Gallenkamp. Pharma-Safe, the solution you have been waiting for, is here.

Modular, quick-build stability test rooms have proven popular. The 'PSR' range provides cost-efficient, large capacity storage for those with high and increasing sample throughput. Offering the same long-term, reliable and accurate performance as the rest of the family, the PSR rooms are installed by a dedicated team of specialists ensuring compliance with our strict validation protocols.

AquaRec UV recirculation purification system

Gone are the days when you need to find a water supply and drain. The Pharma-Safe plus AquaRec UV option means you can locate your stability testing in a place that is convenient for you. A series of purification cartridges and the UV system constantly purifies the drain water from the chamber and delivers good quality water to the humidification system. This recirculating system avoids water loss and requires no drain facility.

Total ICH photostability compliance

Achieving ICH photostability compliance is absolutely guaranteed by Pharma-Safe and not just because its light sources meet criticaI CH technical specifications. By a combination of visible light and near UV, on separate shelves (important for maximum light uniformity), the ICH Q1B recommended exposure test for visible light and UV may be achieved concurrently. As Pharma-Safe is fitted with calibrated precision light sensors, the independent monitoring centre's clever light totaliser function removes all the calculations necessary in ensuring samples meet minimum ICH exposure targets. In fact, each lighted shelf will shut off automatically when pre-set exposure targets are achieved. In addition, as we use mobile light sensors (placing them adjacent to the test samples) you are able to achieve realistic exposure totals for all samples.

Assured testing with automated control of light exposure

The Pharma-Safe system is a total design concept bringing you long-term security for your critical test conditions. Purpose built for ICH Q1A and Q1B test regimes, the Pharma-Safe System incorporates many ideas which ensure maximum safety of your test samples and maximum confidence in your test results. The Pharma-Safe design concept is complemented by a rigorous Validation Protocol. Pharma-Safe; an ideal solution for the quality conscious.

When it comes to large scale stability testing the Pharma-Safe concept is extended to large 'Walk-in' facilities. Designed to embrace the same quality standards found in the Pharma-Safe Stability Chambers, the Gallenkamp 'PSR' Stability Rooms offer standard or custom designs to meet the most demanding installation requirements. With full on and off-site validation packages available on both Pharma-Safe Chambers and 'Walk-in' Rooms, Weiss Gallenkamp really is the one-stop shop for quality Stability Testing facilities.

How Pharma-Safe provides the best environment for validatable tests

The Pharma-Safe units are available with or without the Pharma-Light system as 182 litre and 580 litre versions. Larger size models for stability testing are also available. The use of low maintenance technology and frost-free refrigeration enable long-term tests to be carried out with minimum input, freeing up your time to carry out other important tasks. CFC-free foamed in-place insulation provides maximum thermal efficiency reducing power consumption and running costs. It also enables a more compact, high capacity and space efficient design which can fit through most laboratory doorways. Stability models have a ladder rack system for shelf positions giving total flexibility of shelf spacing.

In combination with the Uni-Flow air conditioning system, this enables efficient use of the working space without compromising the uniformity of the conditions experienced by each sample. The photostability models have insulated shelves spaced at intervals to give optimum lighting conditions, this means all samples receive the same amount of light exposure. Access ports designed for the validation protocols also allow the introduction of independent monitoring of chamber conditions and easy inspection of lighting without the need to open the door during the test procedure. The lightweight construction and the castors fitted as standard on the 580 litre units make for easy installation.

The Pharma-Safe system incorporates a technique for pre-conditioning the air before it enters the sample area. This ensures a homogeneous mixture of temperature and humidity is presented to the Uni-Flow system. The Uni-Flow Air-Conditioning system has an air flow velocity specifically targeted at pharmaceuticals testing and distributes the pre-conditioned air uniformly across all shelves. The Uni-Flow Air-Conditioning system with Pre-Con provides stability and uniformity of the conditioned air, ensuring your samples see exactly the conditions you set on the controller. This means that all your samples are exposed to identical, repeatable and reproducible conditions giving you confidence in your test regime, time after time. Rapid recovery of condition after door opening is also assured.

Many refrigeration systems employ on/off control to achieve temperature and humidity conditions and in most cases this is acceptable. In the world of Stability Testing, a much more sophisticated system is needed to achieve the precise control of temperature and humidity required. The Pharma-Safe range uses a computer to control an electronic expansion valve regulating the amount of refrigerant gas required at any one time for cooling and humidification control. Not only does this give long-term stable conditions with reliable performance, it also provides a frost-free refrigeration system. With no defrost required, the test conditions remain well within ICH guidelines throughout the test period with no unexpected deviations from set point. Other benefits provided by modulated refrigeration control include reduced energy and water consumption, quiet operation and long compressor life reducing the cost of ownership.

Quality components mean quality results and the use of industry leading technology in the combined Pt-100 temperature and capacitance humidity sensor provide the ideal solution in the Pharma-Safe system. Rapid response and negligible long-term drift combined with zero routine maintenance ensure the Pharma-Safe solid state sensor provides the close control required, reliably over the life of the test. The sensor head is removable for easy calibration, it is not necessary to remove all the wires and connections associated with the sensor. Not only does this reduce downtime and inconvenience during re-validation, it is also possible to have a spare pre-calibrated sensor head ready for immediate replacement further reducing downtime. A door within the chamber provides access to the sensor for easy removal of the sensor head. This further simplifies re-calibration and validation. The Pharma-Safe system is designed to keep things running smoothly and continuously.

The Pharma-Light system meets the requirements of the ICH Q1B option 2 test. It includes the Pharma-Light VIS and Pharma-Light UVA lamps and the unique Exposure Equalisation Filter (EEF) to bring exceptional light level uniformity across the whole shelf area. This enables efficient use of shelf space and the maximum number of samples can be placed under test.

The use of calibrated light sensors and overhead, uniform lighting layout means the entire lighting system can be validated. The Pharma-Safe photostability chambers also maintain control of temperature and relative humidity keeping your tests repeatable and reproducible.

The Pharma-Light lamps are easy to change ensuring minimum downtime. For added safety, the end caps are sealed against humidity. Each shelf is insulated to prevent any heat generated by the lamps affecting the samples. This means the only temperature effects that the samples see are the ones you set on the controller giving you confidence in the test results. The interior of the test chamber has a white finish. This is highly reflective and gives a diffused light and increased light uniformity. You can be confident that all your test samples are correctly exposed to the appropriate light level with the unique Pharma-Light system.

The Pharma-Safe Control Panel is at the heart of the Pharma-Safe system. The entire control panel is set out with ease of use as the key requirement. Protection of your critical settings is provided by a transparent locked panel so your settings are protected but remain on view for easy checking.

Advanced Microprocessor PID controllers meet the exacting control tolerances required by the Pharma-Safe system. Precise setting and control of temperature and humidity levels is easy using the simple push-buttons provided. The bright LED displays set and actual values enabling you to quickly check all is well. Use of high quality components and exceptional control performance means the Pharma-Safe system provides much closer control than is specified by the ICH. This guarantees that your tests will be within the required limits from day one and will remain well within ICH guidelines until the test is complete giving total confidence in test results.

Pharma-Light control

Independent control gives Pharma-Safe maximum flexibility while lamp life is monitored by the independent monitoring centre. In addition, a light totaliser function integrates light exposure over time to automatically switch off individual shelves at pre-determined exposure thresholds.

Independent Monitoring Centre: multiple chart recorder options with independent monitoring of temperature, relative humidity, individual shelf light intensity, accumulated lamp life hours, audio/visual/printed deviation alarms, automated text printing of numeric data values, events and alarms to chart. Paperless monitoring systems are available that comply with 21 CFR part 11 allowing for monitoring either locally or remotely via a network.

In keeping with the high quality of the Pharma-Safe system, the multi-function, microprocessor controlled monitoring centre independently monitors and logs temperature, humidity and light. The output is graphical, alphanumeric and there is local audio-visual alarm indication for temperature and relative humidity. If an alarm condition occurs details are printed on the chart but the test continues, however the user is required to acknowledge and clear the alarm condition and this is also printed on the chart. This gives a printed record essential for the audit trail. The Z-Fold chart paper is easy to view through the clear window with a quick view of historical data possible, without unwrapping the paper, by viewing the paper stack contained within the recorder. The monitoring centre lets you know when it needs more paper and will terminate the photostability test at the pre-set light exposure conditions. An optional memory card system enables data transfer to spreadsheet packages for internal requirements. The Pharma-Safe chart recorder provides the output required by the FDA and makes life easier. The paperless versions have the same functionality but data is stored electronically in encrypted form. This encrypted data can be transferred to PC using File Transfer Protocol (FTP) for future reference meaning data storage capacity is virtually limitless.

Sample and test protection

The Pharma-Safe system not only provides a superior test environment it also offers the best possible protection both for your samples and your critical test settings. A door lock and lockable control panel cover prevent sample disturbance and unauthorised changes to test settings. Three levels of protection are provided by the Pharma-Safe system to give maximum security to your samples. The main controller has visual temperature and humidity alarms that activate when actual test conditions deviate from those set by 2ºC or 5% rh. The monitoring centre has local audio-visual alarms for temperature and relative humidity. Overriding all of the above are the user set HI-LO temperature safety thermostats and a power failure indicator all with audio-visual alarm. A remote Alarm Terminal is also provided. Your samples are perfectly protected in the Pharma-Safe system. Additionally, the Pharma-Safe system monitors the water level in the humidifier and an audio-visual alarm sounds if the water level falls to unacceptable levels. This enables easy maintenance of the water supply and ensures the test continues undisturbed throughout the long test periods. Should a critical loss of power occur, the Pharma-Safe system will automatically restart at the point in the test process where the power failed. This means loss of valuable test data is reduced to a minimum. The system status display indicates the current condition of the Pharma-Safe system and also shows any alarm messages enabling users to quickly establish for example, whether a power supply failure has occurred.

Ease of serviceability

The Pharma-Safe system uses the latest electronics technology and Multiple Systems Protection to enhance the long-term reliability required for uninterrupted stability testing. On-board diagnostics and 'quick replace' plug-in components ensure rapid service is possible with minimum disruption and downtime, vital for effective and efficient testing.

Water supply and humidity generation

A Vapour Phase Generator (VPG) positioned remotely from the working chamber provides the humidity requirements in a precise manner by responding quickly and reliably to the demands of the Pharma-Safe system. The action of the VPG sterilises the water supply and remote positioning of the VPG unit traps contamination, both biological and chemical, well away from the working chamber. In addition, a water supply filter provides added protection trapping particulate matter ready for easy routine inspection and removal. Long life and easy serviceability together with low service costs provide the reliability required for long term stability testing. There are three options for the supply of water to the VPG. A direct, pressurised, pure water connector allows the Pharma-Safe unit to be connected to an existing pure water supply. Alternatively, the use of the AquaRec II UV water re-circulating unit provides a stand-alone system where access to a water supply and drain is difficult or inappropriate. The AquaRec II UV also saves money by re-circulating, cleaning and sterilising the purified water. Thirdly, a free standing header tank placed above the Stability chamber gives enough pressure to supply the Pharma-Safe unit.

For further information and pricing, please call Weiss Gallenkamp on 01509 631595 or email enquiries@weiss-gallenkamp.com.