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OneSource Laboratory Relocation

Relocation Strategies for Mission-Critical Lab Equipment in GLP/GMP Regulated Facilities

Introduction

A complex relocation requires extensive planning and thorough, ongoing communication to ensure a smooth process. That’s what it took for OneSource Laboratory Relocation Services to move a global GLP/GMP pharmaceutical and medication delivery company with 14 manufacturing sites, 5 distribution centers, 13,000 employees – and more than $4-billion in sales. Compounding that complexity was the fact that the project included the relocation and recommissioning of three categories of equipment, plus chemicals, across 44 labs. And it entailed moving more than 300 pieces of general lab apparatus and 150 analytical systems encompassing approximately 1,000 items. And that’s not counting the process instrumentation that required white-glove handling and specialized moving equipment.

Designing a Scope of Work that Works

Because moves of this scale require a lot of planning, scheduling, and coordinating, a thorough, comprehensive scope of work is essential. So the first order of business for OneSource Laboratory Relocation Services was to prepare the inventory for relocation, identifying each instrument and its parts; preverifying, qualifying, and validating instrumentation and software; and preparing the regulatory documentation required. From there, the scope of work set forth in a systematic way how the whole team would work toward a smooth, successful relocation. For this pharmaceutical engagement, the scope of work included:

  • Disassembling instruments
  • Safely handling all chemicals and temperature-controlled lab samples
  • Managing transportation or disposal of all hazardous materials
  • Packing and moving
  • Reinstalling all instruments and holistic testing
  • Qualifying/validating, as needed, post-move
  • Handling any obstacles, such as moving oversized equipment


Pre-move Planning Assures Success

Because we’re end-to-end project managers fielding a large, diverse service and support organization, we were able to identify subteams to address niche areas of service too specialized to be handled by support generalists, including hazardous waste management and pre- and post-calibration of sensitive laboratory equipment. In addition, specific tasks were assigned and executed on a tightly managed, efficient workflow schedule (Figure 1). Weekly and biweekly meetings, both onsite and via phone conferences, were called to keep everyone on track, including the corporate team (project managers, Facilities, Engineering, QA, Compliance, scientists, and construction managers) as well as the OneSource team (onsite project managers, scientists, customer service engineers, and support staff). In addition, extended team members were included – for instance, subcontractors charged with moving, chemical waste management, and more.

These tasks, provided directly in house, included:

  • Pre- and post-calibration and qualification
  • Custom qualification protocol development
  • Equipment and accessory labeling
  • Dismantling, packing, setup, and qualification

What’s more, sample handling (-80, -20 °C) and restricted standards custom qualification protocols were developed for all analytical systems.


Special Concerns for GLP/GMP Facilities

To safeguard regulatory compliance, a number of special concerns were addressed in planning and executing the move, including SOPs for decommissioning and recommissioning equipment; handling critical samples and managing chemical waste; and for multivendor service, project management, and IQ/OQ/PQ qualification. In addition, OneSource Laboratory Services provided GLP/GMP training and understanding for regulatory procedures as well as good documentation procedures (GDP) training and execution.


Delivering Real Multivendor Service Expertise

Like most laboratories, this pharmaceutical’s extended lab environment contained a wide spectrum of instrumentation and equipment, from high to low end, from many different vendors. OneSource applied its broad multivendor expertise to decommission, dismantle, move, and recommission the facilities equipment, ensuring an efficient and compliant relocation.


Scheduling and Project Management

Careful project management ensures that a move proceeds smoothly, as planned, and that any changes are addressed. We employ Microsoft® Project to manage, schedule, and track the relocation project at every step (see Figure 2), including:

  • Inventory verification
  • Meetings
  • Labeling/tagging of equipment
  • Equipment relocation
  • Personal items and drawer contents move
  • Creation of IQ/OQ protocols/calibration procedures
  • Decommissioning, moving, setting up, post-calibration, repair, qualification
  • Chemical moving and sample handling
  • Large-equipment moves


Multivendor Compliance Skills

The ability to perform qualification/validation on a variety of instruments from various manufacturers is an essential skill when moving laboratories operating in regulated environments. For this project, we used a document paper trail for each instrument to ensure compliant GMP/GLP status was maintained. In addition, standardized document templates made it easier to maintain and audit each instrument.


Examples of Multivendor Expertise in Laboratory Relocation

In addition to this complex relocation of a major pharmaceutical company, OneSource Laboratory Services has performed this type of relocation with other enterprises that required us to safeguard regulatory compliance while addressing a variety of special requirements, including:

  • Complete lab equipment dismantling, moving, commissioning, and qualification (LC/MS, GC/MS, FT-IR, and other lab equipment) at a U.S. chemical company
  • Complete lab equipment dismantling, moving, commissioning, and qualification (including LC/MS, genomic/proteomics equipment) in four moves in one year at a U.S. biopharmaceutical company
  • Repair and calibration (HPLC, GC/MS and other lab equipment) at a U.S. pharmaceutical company
  • Complete move of several laboratories, including eight high-tech instruments and all lab equipment, for a Swiss biotech company
  • Complete lab equipment relocation for a global testing company in Australia, consolidating three labs into one location
  • Complete HTS lab equipment dismantling, moving, and commissioning, (LC/MS, LH, MLD, Imaging, G.L.E) in three days at a U.S. university

What’s more, we’ve demonstrated our ability to perform multivendor validation, qualification, and calibration. For example, we performed a custom validation of more than 100 systems, including flow cytometers, luminometers, refrigerators, and freezers at a large university medical center; validation of lab, pilot, and production-scale separation systems, DNA synthesizers, and incubators in the GMP manufacturing labs of a large pharmaceutical company; even validation of Tecan Genesis, Beckman Biomek®, CMS, HPLC, plate readers, and UV/Vis spectrophotometers in the GLP labs of a biotechnology company.

What to look for in a relocation service provider

  • Evidence of comprehensive planning
  • Timelines for each project phase
  • Extensive communication
  • Ability to resource as required
  • Use of appropriate management and scheduling tools
  • Processes to verify accuracy (inventory and labeling)
  • Knowledge of compliance requirements, including decommissioning, recommissioning and associated documentation
  • Ability and flexibility to handle unexpected changes and issues
  • Technical multivendor capability and resources to handle the job

Summary

This lab relocation and recommissioning project demonstrates that the complex move of a regulated facility can occur smoothly, without compliance impact. OneSource has the expertise, processes, tools, and project strategies for a relocation of this magnitude, and our approach resulted in a successful move – and real benefits for the client and third-party service providers alike.