Moving complex pharma equipment and systems into your lab is not your everyday project.
In fact, there are a plethora of factors you need to consider as part of the move. Otherwise, you risk damaging extremely sensitive and high-value equipment and precision components.
Our decades of experience working with complex pharma equipment in labs and cleanrooms across the globe has given us deep insight into the key considerations to factor in to ensure a smooth and efficient move.
Here are the seven things to consider as part of your project.
1. Equipment Assessment and Planning
The old saying, “If you fail to plan then you plan to fail” rings especially true for complex pharma equipment moves.
Equipment assessment and planning is where you identify your equipment’s unique requirements and optimise every step of the process to ensure a successful move.
For example, scanners, capsule-filling machines, and tablet coating machines are highly sensitive to environmental conditions and vibration. So you need to plan how you’ll protect equipment and precision components against these factors. Otherwise, you risk equipment damage, delays and more.
Equipment assessment and planning involves:
- A comprehensive equipment audit: Create a complete inventory of all equipment and systems, noting specifications, dimensions, weight and any unique identifiers. Assess equipment condition, pre-existing issues, and special handling requirements.
- Detailed planning: Develop a detailed move blueprint that outlines every step of the relocation process, determining which resources you’ll need at every step and coordinating logistics.
- Communication and documentation: Maintain open lines of communication with all stakeholders involved by holding regular updates. Keep detailed records of the planning process (for example, contracts, insurance policies, transportation documents, and condition reports).
2. Regulatory Compliance
Regulatory compliance is more than a bureaucratic checkpoint. It’s integral to protecting your people and equipment throughout the course of the project and working as efficiently as possible.
However, laboratories operating in regulated industries, or those accredited for specific standards, often face additional layers of complexity. So it’s important to understand all regulations that apply to your lab and equipment so you can meet them effectively.
Here are a few key things to consider:
- Regulatory frameworks: Understand which local and global regulations apply. For example, if you’re buying or importing equipment on GB or EU markets, you’ll need to comply with the UK Conformity Assessment (UKCA) regulations and Conformité Européenne (CE) regulations, respectively.
- Permits and approvals: Identify permits or approvals you might require, including transportation permits for hazardous materials, import/export licenses for equipment crossing international borders and local permits for large or heavy equipment transport.
- Compliance strategies: Conduct a pre-move compliance audit, ensure all personnel involved (including third-party contractors) have sufficient training, and maintain detailed records of all activities throughout.
- Post-move: Ensure equipment has been installed, calibrated and validated according to the same regulatory standards as before the move. Notify relevant regulatory bodies about the project, if applicable.
3. Risk Assessment and Mitigation
Pharma equipment moves that go wrong can cost significant amounts in repairs or replacements, cause weeks (or even months) of delays or impact production.
For example, labelling equipment and sealers are susceptible to misalignment and sensitive to static, which can impact operational precision and, therefore, production. Risk assessment and mitigation strategies, like custom crating with antistatic materials and shock absorption features, help significantly reduce the likelihood of that happening.
Here are the key things you need to consider:
- Risk identification: Assessing equipment vulnerabilities (for example, sensitivity to temperature, humidity, vibration, and shock) and considering environmental and external risks (including adverse weather or risk of contamination during transportation).
- Mitigation strategies: Use specialised packing materials and handling methods to protect equipment during the move and ensure everyone involved is fully trained to protect equipment against damage.
- Contingency planning: Develop plans in the event of any unforeseen changes and secure comprehensive insurance coverage.
- Documentation: Keep detailed records of all identified risks and mitigation strategies.
4. Transportation and Logistics
Safe packing and transportation can be life or death for highly sensitive pharma equipment and precision components.
Freeze dryers and tunnels, for example, need to be kept in strictly controlled temperature environments during transportation to prevent compromise in functionality.
Here are the key things to consider:
- Transportation mode: Consult the equipment OEM to ensure you comply with their recommendations for transport. Mode of transport should be based on the equipment's size, sensitivity, destination, and timeline. Consider features you might need, like climate control, vibration dampening or enhanced security measures.
- Route planning: Identify the safest route for transportation, taking into account road conditions, climate and potential bottlenecks or hazards.
- Packing and handling: Design and manufacture custom packaging that’s tailored to the equipment’s requirements. This might involve working with specialists like us — learn more about our export packing and crate manufacture service here. Develop clear handling instructions, including lifting points, weight distribution, and sensitivity areas.
- Logistics partners: Select logistics partners with proven experience in transporting and handling the specific equipment you’re relocating. We, for example, have been handling complex, high-value pharma equipment since 1991 —learn more about our equipment relocations service here.
5. Installation and Commissioning
Many pieces of lab equipment, such as form fillers and filling lines, require precise calibration to function accurately post-installation.
But, being highly sensitive pieces of equipment, it can be easy to compromise calibration during movement and installation.
So, you’ll need to ensure the equipment functions to its full capacity post-installation. This involves:
- Pre-installation planning: Ensure the destination site has the necessary utilities, environmental controls and space configurations. Create a detailed plan to note timelines, resources and specific installation procedures.
- Installation process: Ensure personnel handle, unpack, assemble, and set up equipment according to the original equipment manufacturer's (OEM) guidelines. Connect and test connections to utilities such as electrical power, water, and gas lines.
- Calibration and validation: Following installation, perform an initial calibration according to the manufacturer's specifications. Then conduct an operational qualification (OQ) and performance qualification (PQ) to verify equipment functions correctly and produces the expected outcomes.
- Documentation: Keep thorough records of installation procedures, calibration data, qualification reports and any deviations or issues.
- Post-installation: Monitor the equipment closely to identify any issues or required adjustments. Perform ongoing maintenance to ensure the equipment continues to perform as required.
6. Infrastructure Readiness
Many pieces of lab equipment (for example, freeze dryers) need to be kept in specific environmental conditions, such as specified temperatures or levels of humidity. Otherwise, you risk compromising functionality and causing irreversible damage to precision components.
You’ll need to ensure your facility meets the necessary conditions to operate efficiently, safely and in compliance with regulatory standards. Consider:
- Facility assessment: Conduct a detailed review of equipment requirements, including power needs (e.g., voltage, frequency), water quality and supply, HVAC specifications, and environmental conditions (such as temperature, humidity, and cleanliness levels). Then, conduct a comprehensive evaluation of the destination lab’s existing infrastructure.
- Gap analysis: Compare equipment requirements against the lab’s infrastructure to identify gaps and areas that need upgrade.
- Upgrades and modifications: Make required upgrades or modifications to your lab’s infrastructure.
- Validation and testing: Conduct comprehensive facility systems testing to verify upgrades and modifications meet the required specifications and comply with local regulations, industry standards and best practices. Implement environmental monitoring systems to continuously track lab conditions.
- Documentation: Keep detailed records of all infrastructure upgrades and modifications, including specifications, test results and compliance certificates.
7. Training and Documentation
Finally, ensure all personnel involved, no matter how big or small a part they have to play, have undergone thorough training on how to safely install, operate and maintain the equipment throughout the process.
For example, operators of capsule filling machines and tablet coating machines need training on the proper handling procedures, so they can minimise mechanical stress and maintain operational efficiency.
As part of this, consider:
- Training programmes: Conduct a needs assessment and develop training modules that cover equipment operation, routine maintenance, troubleshooting, safety procedures and compliance with regulatory standards.
- Comprehensive documentation: Update operation manuals to reflect modifications or upgrades you’ve made to your equipment. Set up maintenance procedures and develop safety protocols.
- Culture of safety and compliance: Provide opportunities for ongoing education and training, appoint safety champions within teams and establish feedback mechanisms to enable workers to report safety concerns.
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For more than 30 years, we’ve been working with complex life sciences, medical and pharmaceutical equipment in laboratories and cleanrooms worldwide.
