Relocation, relocation, relocation; negotiating the potential risks

John Best outlines some of the critical issues that must be considered when choosing a relocation company for the transfer of laboratories, either internally or externally, from facility to facility

Whether you are relocating an entire laboratory within the UK or overseas, or moving a single piece of equipment elsewhere within a building, it is important to bear in mind the potential risks associated, and take steps to minimise these wherever possible.

The landscape is changing significantly in relation to the consolidation and outsourcing of laboratory operations across the life science, pharmaceutical and associated sectors. Organisations are seeking to relocate their laboratory functions to optimise performance, or achieve streamlined running costs, but it is vital to scrutinise the approach to the physical element of the relocation, in order to reduce significant potential risk from financial, scientific and regulatory concerns.

You may choose to employ a full service provider, which includes the offerings from many of the leading original equipment manufacturers (OEM’s), or to source a relocation service separately from the decommissioning and re-commissioning providers. Either way, what is certain is that the chosen relocation company should be able to demonstrate a range of skills and experience far beyond simply being able to pack and move equipment.

It is worth remembering that even the OEM’s will almost certainly sub-contract the physical element of any move and so particular attention should be paid in sourcing a compliance-driven – rather than transport-driven –  relocation company.

The first phase of any relocation is to understand what needs to be moved and make a full inventory. This should include equipment, accessories, samples, chemicals and any other hazardous materials. Make sure you fully identify equipment on an asset list, along with values for the equipment for insurance purposes.

A laboratory relocation can be a complex project, so take time to think about the timescales involved for each element of the move. Keep a record of when you will need equipment, specimens and critical data to be available in your new premises, and allow time in the schedule for good practice (GxP) requirements and regulatory compliance to be met at every stage.

A relocations provider should help your laboratory move run more smoothly and give you proactive advice regarding how to proceed. It is important to choose your partner carefully, to avoid any unexpected problems or oversights which may cause serious issues down the line. By asking any potential relocations provider the following questions before making a decision, you could well save yourself from a host of problems further down the line.

What experience do you have in relocating laboratories? This may seem obvious, but a lot of providers profess to be “specialists”, so ask them how they measure this specialisation. Find out whether they have worked in a good laboratory practice (GLP)/good manufacturing practice (GMP) compliant environment before and whether they understand how they need to operate on site, observing specific laboratory protocols.

It is also important to ensure that your relocation provider has the experience to complete all of the necessary packing requirements at origin and then deliver, unpack and bench all of the equipment at destination, as well as removing all packing debris. A lack of experience could cause costly mistakes or accidents, which may lead to unnecessary delays following your move.

How do you manage the post-move installation, operational and performance qualifications (IQ/OQ/PQ) validation process? A good laboratory relocation provider should work closely with you to understand workflow requirements and uptime sequencing, to ensure that they identify with you the last piece of equipment that can be shut down and the first which is needed to start up.

Understanding of the post move IQ/OQ/PQ validation process is vital to ensure zero or limited downtime and the hand in hand collaboration with any service providers, to reduce risk from the business along with cost.

How do you manage risk associated with working in Cat II or Cat III laboratories? Ensure that your provider’s workforce has experience in working in this type of environment, and has undergone adequate bio-hazard training. Crew members will need to understand simple signage, both in the laboratory and in relation to some of the items they may be asked to relocate, such as flammables, corrosives or infectious substances. Any mishaps in these areas could cause serious harm.

How do you protect laboratory equipment during transit? Equipment cannot simply be moved – it needs to be protected. The levels of protection will vary depending on the equipment, sensitivity, value, weight, size and distance to be moved. Your provider should be able to detail this need, in generic and specific equipment protocols. These will include protocols that can be gained from many of the leading OEM’s and their work must ensure compliance with these protocols.

Many laboratories do not retain OEM packaging, so in this instance ask for assurances from your relocation provider to provide confidence that their bespoke packaging will meet and exceed the needs to ensure a safe transit. Bear in mind that this will ultimately have a positive or negative effect on the post move IQ/OQ/PQ validation process and this is where significant time and money can be lost, during any size or scope of relocation, no matter the distance.

How can you guarantee integrity of temperature controlled specimens? Gauge your potential provider’s knowledge of this subject, if temperature control will form an element of your requirements, and check that any packaging being used is fully validated. If required, can the relocation provider offer validation reports for the temperature controlled packaging that can be provided as part of any required submissions to agencies such as the Food and Drug Administration (FDA) or European Medicines Agency (EMA)?

Even if validated packaging is provided, find out how you can be sure that the temperature integrity of product or samples has been met. There should be mechanisms for temperature logging en-route. Find out how this is recorded and provided upon final delivery, especially for ambient temperature requirements that are being shipped cross-hemisphere, or for unstable temperature ranges such as 2-8°C.

Are you experienced in handling dangerous goods? Make sure your potential provider understand materials safety data sheets (MSDS) and that they can competently pack dangerous goods for road, air or sea transportation where required, producing all of the necessary documentation. The company you choose to provide support for this element of the move should also be able to provide a dangerous goods safety advisor (DGSA) to meet all of the statutory legal requirements in handling substances of this type.

What level of insurance do you provide? The company providing your relocation service will need to have high enough standard liability insurance for goods in transit, or have the capacity to increase their cover to the levels required to sufficiently insure all of your assets. Check whether the insurance will cover mechanical derangement and, if it does not, ensure you understand the limitation of liability in this respect and how this can be safeguarded.

What staff security measures do you have in place? This is particularly vital for projects in laboratories where there are potential threats from animal rights campaigners. Establish whether the team which will handle your move will all be employees of your provider – and then find out the security check process which staff undergo. Find out whether any elements of the service are sub-contracted and, if so, how these are managed.

How do you maintain chain of custody for data? If data is being transferred, check that your provider understands the requirements under GxP to be able to show the “chain of custody”. Find out how you can be sure of the integrity of the data from point of origin to the final destination and what security measures are in place to provide 100% satisfaction that data will remain safe throughout the transit period. If data is compromised you risk having to repeat many hours of research.

Do you track assets? To ensure complete peace of mind during your laboratory relocation, ask your provider to carry out accurate tracking of all assets, including temperature controlled specimens. This will help to ensure that every item is delivered to the correct department at the required time, along with full sign off and receipt logging. Not only will this provide a full record of the location of all items, in case anything goes astray, it will also help to safeguard valuable items.

Do you provide a global operation? If your organisation operates across international boundaries, ensure that your relocation provider is able to match your global footprint. This will ensure, for example, that delivery of service in Asia meets the same criteria and uniformed levels of quality across health and safety, insurance, GxP and regulatory controls, as it will in Europe and the Americas.

By asking the questions above, you should be able to gather enough information to ensure you have minimised the major risks associated with a laboratory move. But don’t forget the basics, too. Always follow up on references, and ask your provider to submit detailed risk and method statements for each part of the move prior to any works taking place. This will enable you to be sure of the safeguards in place for the contractors’ employees, and those of your own organisation, along with other sub-contractors and members of the general public.

Author: John Best is sales director at specialist laboratory relocations provider, Andrew Porter Ltd

Contact: John Best, bestj@andrewporterltd.co.uk