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.
Temperature excursions and what to do to resolve and prevent them is not an issue that has suddenly occurred, 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; Distributors, Manufacturers and Logistics Specialists.
MHRA statistics show that temperature increases above 25°C have been the single biggest issue for those responsible for the storage of pharmaceutical products. 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 potentially cause a health risk to patients. Issues relating to temperature control can cost distributors in a number of ways if not tackled; they can lead to a loss of confidence in the distributor by manufacturers, the MHRA and pharmacists.
Clearly, 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 license, compulsory variation of licenses to exclude certain activities and sanctions against the Responsible Person. The most serious offences could result in distributors losing their licenses.
Tackling The Problem
To help members address this issue, the BAPW developed the Gold Standard, which sets out Good Distribution Practice and endorsed by the MHRA. The reality is, that a warehouse without cooling will not comply with the EC regulations governing the storage of pharmaceutical products.
Average summer temperatures continue to rise at the same time government policy is geared to driving industry to reduce its impact on the environment, so traditional heating, ventilation and cooling (HVAC) systems 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.
The BAPW has been working with Jet Environmental, 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.
“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 low energy consumption and consequently 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 Environmental 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. Jet’s pharmaceutical warehouse cooling systems are bespoke designed to integrate aesthetically with ancillary systems such as lighting, fire curtains and sprinklers.
Importantly, Jet Environmental'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.
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 is easily linked to temperature mapping systems to record temperature over time. A balanced jet system not only monitors temperatures from the sensors but will control the temperature within the operational space in accordance with the MHRA guidelines.
Pharmaceutical Sector Expertise
Jet Environmental has extensive experience in close climate control and understands the needs of the pharmaceutical sector having worked with several of major manufacturers and distributors.
Pfizer Inc., Dublin
Pfizer Inc. is the world's largest pharmaceutical company and has had a manufacturing presence in Dublin since the early 1960s. Pfizer has been manufacturing sterile pharmaceutical products at its 17-acre site since 1972, initially producing a range of diagnostics products before switching to biologic drug products. Drug substance products were added to the portfolio in 1995. In 2006 the facility was developed to increase the aseptic fill and lyophilisation (freeze drying) capacity and a new 2,500m warehouse operating to FDA and EU standards was built.
Five pallets high (18 aisles), the facility incorporates two loading docks and one ramp for incoming materials and one outgoing dock, while an ESFR sprinkler system is installed in the warehouse storage area. Kugler Engineering was awarded the contract to supply a Balanced Jet air induction system that would integrate with the ancillary systems while maintaining internal warehouse temperatures of 23°C and 19°C in the summer and winter respectively.
The bespoke system maintains the design temperature within the warehouse 24/7 all-year round to a set point tolerance of ±2ºC and provides a volume flow rate of 1.5 air changes per hour.
To comply with validation requirements there was extensive documentation of the entire engineering process. System performance was validated using 27 calibrated data loggers located around the warehouse in a three dimensional grid. The temperature at each location was mapped for a continuous period of 63 hours during which time the difference between the highest and lowest measured temperatures was 0.9ºC - well within the 4º tolerance specified.
Pharmacia, Milton Keynes
Employing its unique Balanced Jet technology, JET engineered a self regulating air induction system to supply conditioned air to all areas of Pharmacia's 6,141m² Nimrod Distribution Centre in Milton Keynes.
The facility comprised a densely racked product storage zone and an open plan goods receiving/despatch area so the JET system was configured to achieve a high degree of controlled air movement and even temperature distribution throughout the space. In order to maintain internal temperatures within a 15°C-25°C range and to handle an external ambient temperature ranging from -5°C to 30°C, the system provided heated and cooled air and the ductwork and nozzle outlets were co-ordinated around the racking and an ESFR sprinkler system.
A validated environmental monitoring system (EMS) utilising 90 temperature monitoring points was installed and when checked, to ensure there were no hot or cold spots in the warehouse, the equipment confirmed that the JET system was maintaining temperatures of +/-1°C across the whole facility. Nigel Powell, Pharmacia's Warehouse Distribution Manager, said: “After bringing in calibrated equipment to check the temperature monitors and ensure there were no hot or cold spots, we were delighted to see JET's system deliver temperatures of +/-1°C across the whole facility.”
Healthcare Logistics Bedford
When Healthcare Logistics specified the HVAC solution for its 11,200m² warehouse in Bedford, its prime consideration was precision control over the environment so as to comply with EC regulations on pharmaceuticals storage.
“In order to abide by the stringent product storage rules and the mandatory requirement for continuous monitoring of the environment to ensure products are maintained at optimum temperature, the HVAC solution had to meet strict performance parameters,” said David Ambler, a director of Bennett Williams, which acted as consultant on the project.
“Appropriate cooling and the maintenance of a constant temperature to ensure product quality were of paramount importance.”
An air-based system was therefore the only viable solution. JET devised a system with two direct gas heaters to maintain a specified temperature within the 15°C to 25°C band throughout the operating space. Ductwork was not only co-ordinated around ancillary services such as sprinklers and lighting, but was also installed in the dense 13m high bay racking to ensure optimum airflow.
Utilising Balanced JET technology - which does not feature dampers in the distribution system or at the outlets and so alleviates the need for post-installation adjustment - JET was able to 'fast track' the installation. “We were impressed with JET's ability to work alongside other specialist contractors, co-ordinating what was a complex puzzle at soffit level and ensuring the system was in position on schedule,” adds David Ambler.
Phoenix Healthcare, Birmingham
JET supplied the HVAC solution for Phoenix Healthcare's distribution centre at Hams Hall Distribution Park in Coleshill, near Birmingham, engineering a Balanced Jet system that would maintain a constant temperature of 18°C throughout the facility.
In 2006 Phoenix Healthcare approached JET to discuss upgrading the HVAC system to comply with MHRA requirements. While evaporative cooling was considered during the review, Phoenix dismissed it on the basis that the UK climate makes it unsuitable for a pharmaceutical application, and opted for retro-fit cooling to the existing system.
JET installed cooling only air handing equipment and modified the existing Balanced Jet system to accommodate new racking and MHE, while the revised system also benefited from the addition of condensing units. The system was purpose-designed for a night time purge cycle to minimise daytime cooling requirements - and so reduce mechanical cooling costs - during the summer months. The MHRA conducted an inspection of the facility on the hottest day of 2006 when the outside temperature was 36°C, yet the interior temperature was maintained at a constant 25°C.
Contact Jet Environmental for help reviewing 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 and MHRA's recommendations.