Temperature-controlled storage

Temperature-controlled storage

Temperature-controlled storage for clinical trials

KLIFO provides GxP-compliant, temperature-controlled receipt and storage of clinical trial materials, with integrated project management and EU Importer of Record (IOR) support to keep studies moving without supply risk. Storage at KLIFO is available as part of a wider CTS project, but also as a standalone service to clients either lacking in-house storage capabilities at the appropriate temperature, or who are experience capacity constraints internally.

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Room temperature storage forklift main warehouse 4

Temperature-controlled storage

What this service covers

We receive, quarantine, inspect and release and store clinical trial materials under validated, continuously monitored conditions. Our Clinical Supply Managers (CSMs) coordinate every step—from import and receiving to storage, packaging or distribution.

Key outcomes

  • assured product integrity through validated temperature control and monitoring
  • efficient receiving processes ensure receiving does not become a bottleneck in the CTS process
  • barcoded locations, controlled by KLIFO’s WMS system, supports efficient product retrieval
  • full GxP compliance, complete documentation and audit readiness
  • flexible, scalable capacity across CRT, 2–8 °C, −20 °C and −80 °C
  • secure handling for controlled drugs
  • regular cycle counting ensures inventory accuracy

Temperature-controlled storage

Temperature bands and controls

CRT (15–25 °C)

– Typical products: tablets, capsules, medical devices, ancillaries
– Controls: constant temperature monitoring, 24/7/365 – automated alerts sent to responsible personnel out-of-hours if deviations occur, back up generators

2–8 °C

– Typical products: biologics and vaccines
– Controls: 24/7/365 temperature monitoring, storage can be split across 4 cold rooms to minimise product risk in the event of equipment failure, redundant capacity, back up generators

−20 °C

– Typical products: vaccines, biologics
– Controls: 24/7/365 temperature monitoring, full back up generator support

−80 °C

– Typical products: gene therapies, vaccines
– Controls: 24+ fully validated ULT freezers with redundant capacity in case of equipment failure, 24/7/365 monitoring and alerts, maintenance plans

Controlled drugs (vault)

– Typical products: scheduled/controlled substances
– Controls: authority-approved storage, restricted access vault with dual access control; vault itself is maintained at CRT, but potential to add refrigerated or frozen storage of controlled drugs if needs dictate.

Returns warehouse

– For storage of material returned from clinical trial sites prior to destruction
– Controls: Separate, access controlled warehouse prevents risk of returned material mixing with active CTS inventory.

Temperature-controlled storage

Storage capacity

We combine scalable locations with transparent pricing pallets for bulk, shelves for smaller footprints so you only pay for what you use.

CRT (15–25 °C)

– 1,700 pallets
– 1,500+ shelves (90×60×50 cm)
– Guided forklift allows use of space to be maximised without risk of product damage

Refrigerated (2–8 °C)

– 490 pallets across 4 cold rooms
– 1,160 shelves (100×60×46 cm)

Walk-in freezers (−20 °C)

– 12 pallets
– 225 shelves (150×60×50 cm)

Upright freezers (−80 °C)

– 96+ shelves (85×60×30 cm)

Klifo, Glostrup. 15/10-2025

Temperature-controlled storage

How we keep your materials protected

  • Validated environments: temperature mapping, qualification and change control
  • Continuous monitoring: calibrated sensors, automated alerts, 24/7 escalation
  • Receiving & quarantine: visual checks, seal verification, quantity reconciliation, WMS status controls
  • Deviation management: documented investigations, impact assessment and CAPA
  • Security: restricted access areas, audit trails, vault storage for controlled drugs
  • Distribution-ready: seamless hand-off of received materials to packaging and global distribution when required, helping minimise project start up times

Temperature-controlled storage

Importer of record (IOR) services

For shipments into the EU, KLIFO can act as IOR to simplify customs and regulatory processes. KLIFO’s goal is to ensure that our IOR processes do not create an unnecessary burden for the client. In addition to providing EU IOR services, KLIFO is also able to perform foreign IOR for shipments from the EU to US.
On arrival, products are received into quarantine, verified, documented and released to the appropriate temperature zone—reducing cycle time and administrative burden for your team.

-80 freezer 2

Integrated with clinical supply management

KLIFO’s CSMs lead your storage workstream as part of an end-to-end clinical supply plan: label and kit design, comparator/ancillary sourcing, packaging campaigns, depot setup, expiry updates, returns and destruction.

Guidance through every phase

KLIFO’s storage capacity is available to all clients, regardless of their stage of development. Whether your storage requirements cover API, finished dose forms or packaged clinical trial kits, KLIFO can support your requirements regardless of scale.

Why klifo

  • capacity where it matters: significant headroom in 2–8 °C, −20 °C and −80 °C to absorb peaks and program growth
  • storage-only friendly: we welcome storage-only contracts—ideal when you need space now and flexibility later
  • cost-transparent locations: pay for pallet or shelf space as used; no one-size-fits-all “location” fees
  • operational agility: rapid onboarding, short-notice receiving and fast release to storage
  • sponsor-side experience: senior CSMs with decades of hands-on biotech/pharma insight
  • one team, fewer hand-offs: IOR, receiving, storage and onward clinical logistics under one roof
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Room temperature storage forklift main warehouse 4

What you receive

  • Compliant EU import and receiving (when we act as IOR)
  • Documented storage under the required temperature band(s)
  • Continuous temperature records and audit-ready documentation
  • Inventory visibility and status control through our WMS
  • Deviation reports and CAPA when applicable
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Through collaboration, we can harness our combined expertise and ensure proper project implementation to ensure that your organisation benefits in both the short and long term.

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