Jeremy Cassady, MD for Securikey, looks at the importance of storing pharmaceuticals in a secure facility within a controlled environment and examines how Modular Vault systems can offer a cost-effective, easy-to-install bespoke security system that meets all requirements.
According to a recent report brought out by the Association of the British Pharmaceutical Industry (ABPI), the UK pharmaceutical industry now makes a greater contribution to the nation’s economy than any other industrial sector. It is therefore not surprising that, as the industry continues to grow, the requirement for pharmaceutical warehouses or specialised storage areas is also on the rise, as these play a vital role in the safe distribution of medicinal products.
In order to be granted a dealer’s licence to distribute medicinal products, pharmaceutical manufacturers and wholesalers must ensure that the premises intended for storage meet all the requirements of a licensing authority such as the MHRA (Medicines and Healthcare products Regulatory Agency) or the Home Office. Approval must be granted by the appropriate authority, after a process in which the manufacturer/wholesaler must provide a variety of information including their intended arrangements for transporting the goods into storage, their plans for ensuring satisfactory turnover of stock and how they intend to maintain detailed records. The storage facility must therefore be built to support the logistics necessary to carry out these plans. Licences are granted based on specific criteria and the type of drug being stored, which means that a new application will be required if, for instance, a company wins a contract to distribute a new type of drug.
It is little wonder that the process is so meticulous; leading companies working in the pharmaceutical sector go to great lengths to ensure that the medicinal products they distribute are sourced from reliable manufacturers who are regularly inspected and audited to ensure consistent high quality. It is therefore imperative that all medicinal products are also carefully monitored from procurement through to customer delivery to ensure their quality is not compromised at any stage, thereby preventing contamination or theft of medicinal products throughout the process.
In order to attain appropriate storage facilities that meet requirements and provide the proper conditions for drug storage and stock control, distributors have a few choices. They can commission their own building, which is very costly and time consuming, and a suitable site will also need to be found that will meet all of the logistical requirements. Another option is to hire suitable premises; however, it can also be very time-consuming to find the perfect storage facility to meet very specific needs. As storage facilities are often required within a short timescale after contracts are tendered and won, both options are not always ideal.
One of the most effective solutions is to install a Modular Vault. Offering a completely bespoke, on-site-assembled security room to fit an allocated space, Modular Vaults are increasingly specified by those companies expanding to distribute more medicinal products, as they not only offer a high security option, they are also relatively quick and easy to install and provide a controlled environment.
Offering a five-sided solution if necessary – a common requirement in the pharmaceuticals market – the components are manufactured off-site to fit the precise specification required by each application, which can be in either a new or existing building. The measurements and precise customer requirements will have been established during a comprehensive survey, before being delivered to site as individual panels and welded securely into place. Customised furnishing capabilities such as cabinet and rack systems allow medicinal products to be stored off the floor, and a variety of different locks can be selected for the door depending on the level of security required.
Ventilation and Alarms
Pharmaceutical products are vulnerable to temperature and humidity fluctuations and must therefore be stored in a carefully controlled environment. To meet this important requirement, Modular Vaults offer the option of integrating certified airing, ventilation and alarm systems throughout the vault room via customised openings in the walls and door. The best ventilation system to meet the brief will be established as part of the consultation process, and will depend on a wide variety of aspects such as the type of drug being stored and the manufacturer’s instructions for storage, vault size and planned usage.
Due to their adaptability, Modular Vault solutions are also used in other industries, such as the storage of money in banks, casinos and for cash in transit companies, as well as in the storage of precious stones for jewellers. These customers can also benefit from customised furnishing within Modular Vaults, with the additional options of mechanical or electronic deposit boxes. When selecting a vault, buyers are advised to ensure it complies with European security standard EN1143-1 which ensures European wide approval. In addition, the vault should be validated by an independent testing house such as the VdS in Germany to prove it meets the stringent criteria to resist attack.
Modular Vaults in Action
Securikey recently delivered a Modulprim Modular Vault solution to Associated Security Solutions Ltd, who specified and installed the product for a pharmaceutical client based in Staffordshire. The client had just won a new contract to distribute the drug methadone and required a vault that would meet stringent Home Office standards, which are based on The Misuse of Drugs Regulations 2001 and The Controlled Drugs (Supervision of Management and Use) Regulations 2006. Methadone is a drug that is most regularly used in the treatment of addiction to opioids (typically heroine) as replacement therapy. Administered over a prolonged period, in some cases indefinitely, methadone relieves the unpleasant symptoms associated with this type of drug withdrawal. Of course, as it contains opiate and works on the same receptors in the brain as heroine, it is also extremely valuable on the open street. It was therefore vital that the client’s allocated storage facilities offered an extremely high level of security in order to meet the requirements for the safe storage of narcotics.
The bespoke nature of the Modular Vault system allowed the pharmaceutical client to meet the precise specification for a storage environment that was appropriate for methadone, which would have been outlined in the drug manufacturer’s guidelines. The result is a purpose-designed temperature regulated secure storage room that also facilitates the client’s streamlined management system, which would have been stipulated in the licensing agreement, allowing employees to maintain detailed records of the drug batches that are coming and going. In this particular installation, a designated employee will need to be in the vault for a few hours in the morning and evening to record the batch numbers, before bringing the drugs out for distribution. To prevent opportunists from walking in through an open door, specifically-sized grill gates have been installed in the wall so employees can pass the boxed methadone through to be distributed while the door remains firmly closed.
Andy Palmer, European Sales Director at Associated Security Solutions Ltd., explained: “The most important aspect of Modular Vault installations is establishing exactly what the client needs and then, when on site, measuring the area meticulously and keeping an eye out for any potential challenges. In this instance, the vault was being installed in an existing room so, on the plus side, we had a pre-concreted floor to work on which meant we didn’t need to build this. However, we also had width restrictions as well as three large pillars taking up space in the centre of the room.
Deciding on the correct location for the vault is an intricate process and measurement is critical to the millimetre – from the positioning of the walls to the fixings that need to be welded onto the walls for the ventilation and other systems. Getting this stage right, however, ensures there are no time-consuming modifications required later in the installation.
Andy continued: “Once the measurements, positioning and required features were agreed, I liaised with the contractors in charge of the cameras, alarms, data point power socket, air conditioning, fire alarm and sprinkler systems. Securikey ensured that the vault components were prefabricated off-site to precisely fit the measurements, before delivering them as separate panels to site. Installation was straightforward and the vault was completed within three weeks.”
Due to the nature of the pharmaceutical industry, a ‘one size fits all’ solution for secure storage is rarely an option. The adaptability of the Modular Vault solution is one of its primary benefits and, when sourced from a reliable supplier and installed by an experienced company, customers can rest assured that they can achieve the security solution best suited to their needs, their timescale and their budget.