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Pharma

Alexion

New Cold chain warehouse consisting of -20C Freezer room, +2°C/+8°C Thaw Room & +2°C/+8°C Bulk Cold Room.

The scope of this project is to facilitate a purpose build pharmaceutical warehouse extension to ensure increased business opportunity for global distribution of Vaccines.

Client Challenge

Provision of Design & Build Services associated with the installation and subsequent commissioning of the required cold rooms 2-8°C & -20°C for the project with performance to include the supply of all necessary resources required in the development of the detailed design to comply with the requirements of the clients User requirement specification, project schedule & key milestone construction dates for an agreed fixed price lump sum.

The specialist contractor was responsible for the supply of all reports, data, returns, programs, progress reports and all other documentation required under the specific design & build contract.

The specialist was to include for all testing of the works and delivery of construction elements adhering to RIAI conditions of the contract.

The specific temperature controlled chambers were required to be delivered to meet a specific 2 hour fire rating enclosure which comprises to the provision of labour, materials, plant, equipment comprising also of proprietary modular flush wall and flush ceiling systems to meet the specification requirements including all interfaces to ensure a fully functioning and integrate walk in cold room & freezer.

The walk-in cold-rooms & freezer were to be housed within the new proposed AAMF Centralised GMP Warehouse:

  • 2 ºC to 8 ºC Cold Storage; W761. Internal Dims 11.4m (D) x 4.9m (W) x 12.7m (H). External Dims 12.4m (D) x 5.6m (W) x 13.7m (H) (including 2-hour fire rated compartment).
  • 2 ºC to 8 ºC Thaw Room Cold Storage; W095. Internal Dims 5.6m (D) x 4.5m (W) x 7.8m (H). External Dims 6.3m (D) x 5.6m (W) x 9.0m (H) (including 2-hour fire rated compartment).
  • -20 ºC Freezer Storage; W100 11.4m (D) x 4.9m (W) x 8.8m (H). Internal Dims 11.4m (D) x 5.1m (W) x 7.8m (H). External Dims 12.1m (D) x 5.8m (W) x 9.0m (H) (including 2-hour fire rated compartment).

The 2-8°C & -20°C walk in cold rooms are designed to operate to store time & temperature sensitive pharmaceutical material in the form of highly valuable finished product bulk storage substance.

The walk in cold rooms were to be fitted with rapid rise doors to accommodate the use of client VNA trucks access.

Each temperature controlled room required an independent temperature monitoring system.

necessary labour, materials, consumables, resources, tools, equipment and devices required for the complete design, commissioning, support to Sanofi, validation to meet HPRA requirements, training & handover package.

Time, budget, or operational constraints – Control rooms to be designed to maintain temperatures within 2-8°C and -15 to -25°C with control and independent sensors of max 0.5°C of accuracy.

Any technical, logistical, or regulatory challenges – The refrigerant systems designed to provide 100% redundancy of services to the Freezer Storage and Cold Storage Rooms. A minimum of 2 no. refrigerant circuits will be provided to each walk-in cold-room.

Site-specific considerations – A Revit© 2020 3D Model to LOD350 to be developed and released for the walk-in cold-room’s. The walk-in cold-rooms supply specialist was responsible for developing the walk-in coldrooms model to LOD350 to suit the clients design, fabrication and construction details and also  to produce“fly through” reviews on salient aspects of the design.

The walk-in cold-rooms specialist was responsible for turnkey delivery of Cold Rooms and 2-hour fire-rated compartment and responsible for updating the model to provide an “As Built” record of the construction package which will be fed back into the overall coordinated model.

Our Solution

CTS included for the design, supply, installation, site supervision and commissioning/qualification of the complete package of walk-in cold-rooms, and 2 hour fire compartment inclusive of, cold room status feedback to site networks, open door, healthy and common alarm, security system, Data Logger system within the area; including full Lighting systems to facilitate clear and easy access to the walk-in cold-rooms, emergency lighting to Irish Regulations, access control as set out in the clients specification, heat rejection systems, refrigerant control system to each walk in cold-rooms and any other environmental system to ensure the installation maintains even temperature throughout the walk-in cold-rooms and support rooms.

Control Panel

The control section for each of the systems control panels and all HMI panels were provided with a UPS supply to reduce risk of data loss and ensure availability of trend logging in the event of normal power supply failure.

E-stops were provided in each control panel, with an additional 2no. E-stops at Personal trap alarm on each of the walk-in cold-room. Door interlock & access control also formed part of the CTS scope.

The scope of equipment provided included:

  • The supply, installation and commissioning of room refrigeration systems necessary for maintaining Walk-in cold-room in accordance with the environmental conditions specified.
  • The refrigeration compressor units air cooled low noise  type with external condensers.
  • Electrical power supply distribution to equipment and all interconnecting electrical wiring.
  • Integrated controls and associated controls wiring. Complete with Hard and Soft alarms to the Client’s MCS system as outlined elsewhere. Preference is to comply to F-gas regulations as the refrigerant system.

The scope of equipment (cont.)

  • Walk-in coldrooms 2 ºC to 8 ºC refrigeration systems were based and comply to F-gas regulations refrigerant. Freezer -20 ºC  refrigeration systems also based and comply to F-gas regulations refrigerant.
  • A 2 ºC to 8 ºC Cold Room as a Cold Storage and Thaw Room.
  • A -20 ºC Freezer Storage walk-in cold-room.
  • Systems and equipment provided on an N+1 or Duty/Standby redundancy basis to ensure continuity of supply, in the event of plant failure.
  • Gas detection system to included with in package.

Full Validation Package

CTS successfully provided a full validation package inclusive of temperature mapping & functions operation testing to meet HPRA requirements. The system plant compromises of low GWP refrigerant R448a 2 stage reciprocating compressor plants and energy efficient evaporators with EC fan technology and multi section duty/standby control panels.

Specification

100% Duty/Standby facility to meet strict -35°C close temperature controlled environment throughout the entire freezer environment from FFL to ceiling including all of the 5 tiers of specialist bespoke stainless steel racking also provided by CTS.

Implementation

Based on CTS previous vast experience of  low temperature environments & the solution was formulated from extensive knowledge of temperature controlled environments & in specific with previous low temperature fit outs of similar stature.

Outcome

These rooms were designed and constructed with insulated modular wall, and ceiling panels, including all doors, controls, gauges, internal lighting, and other ancillary items required for a completely fabricated and operational walk-in Cold Room, Thaw Room & Freezer Room system.

Maintaining consistent temperature between +2 ºC and +8 ºC. & -20°C and -25°C . The rooms provide a set temperature+/-1.0 ºC of between 2 ºC and 8 ºC & -20°C and -25°C, during loaded conditions. Thawing activities in the Room did not impact on the specification and temperature uniformity (2ºC – 8 ºC) of the room and a full CFD analysis was incorporated to illustrate this during systems commissioning .

CTS complied with all provisions within the construction specification in regards to:

Site facilities, EHS requirements, work planning & progress management, equipment & materials management, equipment installation, access & egress, permitting, provision of scaffolding, construction safety, quality assurance planning & control, mechanical & electrical completion & site procedures during the project to deliver the successful project .

CTS have continued to service & maintain the site in Alexion regularly since handover in August 2024. Regular service & maintenance is provided by in house CTS engineers on a quarterly basis offering continuous support to the Alexion utilities team on site.