Pharmaceutical warehouses hvac:
Managing temperature control in pharmaceutical warehouses
The Medicines and Healthcare Produces Regulatory Agency (MHRA) reports that temperature rises above desired parameters are the number one critical deficiency in pharmaceutical warehouses. It is not the general conditions that affect product quality, but extremes of temperature within the operational space. As global warming is widely accepted as a reality, temperature control issues are likely to become even more of a problem in warehouses that are not equipped with appropriate cooling.
(Full details are available in a special presentation, developed by Jet for BAPW members, which you can download from http://www.jetenvironmental.com/pharma/default.asp. Alternatively contact Steve Ball for a copy on 0121 788 5319)
Introduction
Temperature excursions and what to do to resolve, and prevent them is not an issue that has suddenly cropped up, but one that is taking on greater significance following improvements in warehouse construction. Buildings are better insulated, more air tight and thermally efficient thanks to stringent building regulations, so the issue is no longer how to make sure a building is warm in the winter, but how to keep it cool in light of the higher external summertime temperatures we are experiencing.
This issue is of relevance to many within the pharmaceutical sector, not only distributors, but manufacturers who act in the capacity of distribution and logistics specialists who take on big pharmaceutical storage/distribution contracts.
The issue
MHRA statistics show that temperature increases above 25°C have been the single biggest issue for those responsible for the storage of pharmaceutical products for the past five years.
Temperature excursions are serious because non-compliance with the manufacturer's storage recommendations and the MHRA's guidelines on general storage can lead to expensive product recalls, may prompt the destruction of affected products and, ultimately, could cause a health risk to patients. Issues relating to temperature control will cost the distributor in a number of ways, especially since they can lead to a loss of confidence in the distributor by manufacturers, the MHRA and pharmacists.
Glossing over temperature control issues is not an option since the MHRA’s Orange Guide makes it clear that distributors must comply with the regulations or face sanctions if their facilities are found to be wanting. Adverse inspections will trigger recommendations for corrective action and if it is not taken the MHRA can take regulatory action. This may include suspension of a manufacturer’s or wholesale distribution licence, compulsory variation of licences to exclude certain activities and sanctions against the Responsible Person. The most serious offences could result in distributors losing their licences.
Tackling the problem
To help members address this issue the BAPW developed the Gold Standard, which sets out Good Distribution Practice and is endorsed by the MHRA.
The fact remains, however, that a warehouse without cooling will not comply with the EC regulations governing the storage of pharmaceutical products if we continue to experience high external summertime temperatures. 2006 was the hottest on record, while 2007 is forecast to be hotter still and government policy is geared to driving industry to reduce its impact on the environment, so traditional HVAC are not the answer.
Advice on achieving effective temperature control
We recommend that you seek independent, professional advice to ensure the heating and ventilation systems in your existing warehouse facilities and those you specify for new-build developments provide appropriate cooling so that you do not fall foul of the regulations.
The BAPW has been working with Jet Environmental (Jet), a specialist in cost-effective air induction based systems, so that we can advise how you can maintain temperatures within the allowed parameters across the operational space.
Jet has agreed to undertake a free survey, reviewing existing HVAC systems and advising on ventilation and cooling issues to help you ensure your distribution facilities comply with the EC regulations and will pass an MHRA inspection with flying colours.
“Given the growing body of evidence that CO² emissions are contributing to global warming, our aim is to help pharmaceutical distributors store temperature sensitive products safely by designing systems with a low carbon footprint,” says Jet operations director Steve Ball.
“Unlike traditional systems, which pump more greenhouse gases into the environment, exacerbating the problem over the long term, we engineer our systems to maximise ‘free’ cooling so that the chiller plant is only operational when daytime external temperatures are exceptionally high.”
Jet solutions
Jet specialises in HVAC solutions that utilise its technologically advanced Balanced Jet air induction systems. Air flow and temperature throughout the operational space is maintained at +/- 1°C of the desired level, as the systems are purpose-designed to entrain and recycle heat outputs from MHE; cope with tall, densely racked aisles, mezzanine areas and loading bays and integrate aesthetically with ancillary systems such as lighting, fire curtains and sprinklers.
Importantly, Jet’s systems are engineered to deliver free cooling via a night time purge, when external air temperatures are lower, reducing the reliance on mechanical cooling and so helping to reduce operating costs over the system’s life cycle.
Full details are available in a special presentation, developed by Jet for BAPW members, which you can download from http://www.jetenvironmental.com/pharma/default.asp. Alternatively contact Steve Ball for a copy on 0121 788 5319.
The MHRA recommends data logging to ensure a facility is complying with the regulations. The latest monitoring devices use radio frequency and enable temperature information recorded in a number of areas at different times to be downloaded for analysis. Since Balanced Jet systems require sensors throughout the operational space to control the system, this information can easily be linked to temperature mapping systems to record temperature against time. A Balanced Jet system will not only monitor temperatures from the sensors but will control the temperature within the operational space in accordance with the MHRA guidelines.
Summary
The experts are forecasting very hot summer temperatures in the future and as the Government prepares to unveil its Climate Bill policy designed to force industry to implement energy efficient/low carbon solutions you simply cannot afford to ignore the issue of temperature control.
We recommend that you act now and enlist Jet’s help to review your warehousing facilities and find out what actions you need to take to ensure pharmaceutical products are stored safely in accordance with the manufacturer’s recommendations and the MHRA’s regulations governing general storage.
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