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March 20th, 2019

Temperature mapping an aircraft – a case study

Purpose

The majority of the pharmaceutical (temperature controlled) supply chain has been well qualified and documented over a number of years within the most common areas, such as warehousing, cold storage and vehicles. However there has been very limited work carried out to fully understand the conditions that are experienced in the cargo holds of aircraft used for the transportation of temperature sensitive pharmaceutical products.

For this reason, Biomap and Pharmafreight decided to partner up and use their respective areas of expertise to undertake the challenging process of mapping an aircraft during a live flight, to understand the temperature profile during flight and any risk areas that were highlighted in the recorded data.

Biomap would offer the resource and expertise for the mapping element, and Pharmafreight would utilise its relationships with the airlines and freight forwarding expertise in preparing pharma consignments for carriage by airfreight.

Sourcing the Right Partner

A number of airlines offering a pharmaceutical service were approached to support the project by allowing access to their aircraft for the mapping exercise.  We knew this would be a complex task in light of the tight security around accessing aircraft and freight during the loading process at the airport.  We also wanted to be able to share the data with industry by presenting the results at various professional discussion forums and seminars, whatever the data gathered showed, good or bad.

Etihad Airways were one of the carriers approached, as we knew that in addition to its core activity of passenger transportation, they also operated a significant cargo section perfect for the joint study.  Etihad were incredibly supportive of the project scope from the start, as it had been looking to develop the transportation side of its cargo operations for pharmaceutical products, and there would be huge value in being able to demonstrate the temperature performance of a cargo hold of their aircraft during flight.

Etihad Airways is the second-largest airline of the United Arab Emirates, and commenced operations in November 2003 with its head office in Khalifa City, Abu Dhabi, near Abu Dhabi International Airport.  It operates a fleet of 120 narrow and wide-body Airbus and Boeing aircraft within the Middle East, Europe, Asia, North America, Canada and Australia. This equates to more than 1,000 flights per week to over 110 passenger and cargo destinations.

The Process

Biomap and Pharmafreight proposed a solution and Etihad kindly agreed to offer an aircraft for the project, and a date was agreed.  Biomap raised a comprehensive protocol and plan documenting the suggested approach to map a Boeing B777, one of the most commonly used aircrafts used for this type of freight.   From the outset the project reminded us how quickly things can change with airfreight when at the last minute, the operating aircraft was changed from a B777 to an Airbus A330-200.  Not an ideal situation as the protocol and plans were designed for the B777 configuration.  This meant a speedy redesign of the protocol and logger placement requiring approval before we could commence.  This was achieved and the mapping process continued with the new protocol.

The initial exercise was conducted during winter at Manchester Airport – United Kingdom, to Abu Dhabi International Airport – United Arab Emirates, where it is generally quite warm all year around, with an approximate flight time of seven hours. The mapping study would determine if any hot and cold spots would occur during the exercise, and look to highlight any temperature issues experienced during flight.

The Result

A full temperature mapping exercise was conducted with data loggers positioned throughout the cargo hold (see fig.1) where the pharmaceutical products were transported, and a number of temperature excursions were recorded between the departure and arrival times.

Biomap and Pharmafreight staff supported the installation at Manchester Airport, while Etihad personnel located and retrieved the data loggers at Abu Dhabi Airport, once the flight was complete. These were then handed back to Biomap’s offices in London for processing and data assessment.

Once this was complete, full reports for the hold conditions during flight were produced. This included full graphical and summary data, as well as detailed analysis of the temperature performance and full reports were then submitted for review.

The Next Steps

As the initial aircraft for the mapping exercise had changed on the day of the flight, the project will be repeated with a B777 as originally planned. This particular aircraft is the most commonly used by the Etihad fleet for transporting pharmaceutical products.

September 12th, 2017

Pharmaceutical temperature controlled GDP warehousing MHRA approved

Pharma warehouse

Pharmaceutical temperature controlled GDP warehousing MHRA approved

NEWS: Pharmaceutical temperature controlled GDP neutral warehousing, MHRA approved. Pharmafreight UK holds its own MHRA Wholesale Dealer’s Authorisation (WDA), allowing it to store medicines and related products at its warehouse at London Heathrow. The site is fully compliant with the GDP requirements, with its key features as follows:

  • Over 400+ Euro pallet positions available
  • Storage at both +2 to 8’C and +15 to +25’C
  • Smaller LabCold fridges for product pack storage
  • Fully temperature-controlled warehouse
  • Continuous temperature monitoring system in place
  • Storage, pick-and-pack services available
  • CCTV, Police-linked alarm
  • Fire alarm system
  • AEO
  • Short-term contracts available
  • Fully temperature-mapped facilities
  • Audits welcomed
  • Large variety of storage options, including state-of-the-art chilled/temperate facilities.
  • Envirotainer, CSafe etc. loading under controlled conditions

Pharmafreight also offers our dedicated temperature-mapped vans for deliveries throughout the UK and Europe manned by GDP trained drivers.
Our overseas Pharmafreight partners can also offer a variety of GDP-compliant storage solutions, depending on a client’s requirements. Please ask us about these today!

Contact us at info (at) pharmafreight.com or 01784 248636 – Andy Hughes

C Safe containers at Unit 22

Pharmaceutical temperature controlled GDP warehousing MHRA approved

October 3rd, 2016

Pharmafreight AGM – Barcelona 2016

Pharmafreight held its AGM in October in Barcelona this year. The annual meeting of Pharmafreight licensed partners is held one day before the start of the annual CPhI global pharmaceutical meeting place exhibition. This year’s AGM and presentations dealt with the ongoing GDP audit roll-out of all global Pharmafreight partners to a common standard.

2016-10-03-10-50-53

May 12th, 2014

Pharmafreight now holds MHRA licence for its London Heathrow facility

Pharmafreight is pleased to announce it now holds an MHRA Wholesale Dealer’s Authorisation, allowing it to store and transport medicines through its London Heathrow site.

Following a successful application and subsequent audit from the UK’s health regulator, the MHRA (Medicines and Healthcare products Regulatory Agency), Pharmafreight is now one of only a handful of UK freight companies that holds a Wholesale Dealer’s Authorisation (WDA), allowing it to store medicinal and related products at its temperature-controlled facility in Ashford, Middlesex, just outside London Heathrow Airport. The WDA also confirms Pharmafreight complies with the new Good Distribution Practice (GDP) Guidelines, designed to ensure that patient safety is upmost in a company’s mind, and that the efficacy of a drug is not affected whilst in a licence holders’ care.

Pharmafreight started working in the pharmaceutical forwarding industry back in the 1990’s through its parent company, Mach II Shipping. At that time it was relatively unheard of for a freight forwarder to understand and work to the regulations that pharmaceutical companies had to abide by. Having identified a gap in the market for a specialist freight forwarder dealing only in pharmaceuticals, the Pharmafreight division and brand was established, recruiting like-minded overseas freight companies into its own network, all designed to work to GDP.

During the European Commission’s consultation period last year on the new GDP Guidelines, it was initially suggested that any company in the supply chain holding product for more than 24 hours would need to have a WDA, which would have meant that any airline, transport or warehouse company could potentially need a licence. However this was eventually watered down so that a licence holder must only “minimise” the amount of time that its product is in an unlicensed facility. Despite this Pharmafreight decided that it still wanted to demonstrate to the pharmaceutical industry its aim to be associated with quality in the supply chain, and applied for a WDA licence anyway. Its successful application means that Pharmafreight can now store medicines at its facility for longer than a day, in accordance with GDP, and in the right temperature and quality conditions.

Andy Hughes, Commercial Director at Pharmafreight, said: “We are very pleased to be only one of a handful of independent freight forwarding companies that holds a Wholesale Dealer’s Authorisation in the UK. Pharma companies using our services can take some comfort that we are working to exactly the same legal requirements they are, fully compliant in GDP. And we apply these standards whether we are storing a product on a customer’s behalf, or indeed transporting a shipment halfway across the world.”

For further information about Pharmafreight and its services, please visit www.pharmafreight.com or e-mail info@ pharmafreight.com

March 10th, 2014

Pharmafreight appoints new partner in Canada

Pharmafreight is very pleased to announce the appointment of Geo Express International as its latest licensed partner, looking after Canada for the Group.

Pharmafreight has known Geo Express for a while now, and it has a good reputation in the clinical trial logistics market. It has been in operation since 1979 and specialises in several niche markets, including Health Sciences. Its specific offerings include:

– 24/7/365 door to door transportation of time and temperature sensitive material worldwide
– Clinical Trial Logistics of IMP, ancillary supplies and biological samples for safety/efficacy testing as well as for PK, PG, PD and biomarker assessments
– CTM depot services for drug storage and distribution (ambient, refrigerated and frozen)
– Cold Chain Management including packaging validation and provision/replenishment of refrigerants, packaging, and data loggers
– Health Canada Classified Distributor under HPFB Inspectorate GMP guidelines
– Health Canada Establishment License for the importation and distribution of Pharmaceuticals, NPNs, and Medical devices
– Canada Customs (CBSA) Bonded Warehouse License for temp-controlled imports specific to the Health Sciences industry

For further information please visit www.geoexpressinternational.com/health-services.html

If you have any requests for Canada please e-mail info@pharmafreight.com at this time.

February 10th, 2014

Pharmafreight appoints new partner for Denmark, Finland and Sweden

Pharmafreight is very pleased to announce the appointment of a new partner to look after Denmark, Finland and Sweden.

Following a successful onsite visit to its operation in Copenhagen, Denmark, Pharmafreight has appointed the Finnish CHS Group – incorporating the AirLog Group in Denmark and Sweden – as its new partner for the region. The company has already been working in the clinical trial sector for several years now, providing temperature-controlled packaging and data loggers for its clients, as well as know-how on how to conduct clinical trials and handle pharmaceutical logistics. The company has completed Pharmafreight’s pre-application process, where all of its operations are audited against the new GDP Guidelines, before being appointed to the network. The company’s staff will now be required to undertake further GDP training via Pharmafreight’s online training centre.

For further information about CHS and AirLog, please visit the country pages on this website, or e-mail info@pharmafreight.com

November 23rd, 2013

Video: The opening of the Lufthansa Cargo Cool Center

November 12th, 2013

Video: New British Airways Constant Climate Facility at LHR

October 29th, 2013

Revised EU GDP guidelines (2013/C 68/01) in various languages

October 7th, 2013

US Customs Agencies update after shutdown

Following the US Government shutdown last week, some consignments being moved into the US have felt the affects of the reduced services now being operated by many of the border agencies involved. What follows is a brief update on governmental services affecting the trade community after nearly one week of the government shutdown.  The information provided is a general statement on the state of affairs within the mentioned organization–some government services are performed inconsistently throughout the nation depending on local circumstances.

CBP

Customs and Border Protection is retaining 88% of its personnel.  There should be no impact on entry processing unless the merchandise is subjected to other agency approval.

CBP’s website is not actively being managed during the shutdown.  Delays can occur in processing cancellations, deletions and corrections.  Client representative offices are closed.  The Revenue Division Bond Filing Section will continue to process bond requests but expect delays due to the reduced amount of personnel.

FDA

Most FDA offices report that processing import documents, examination and sampling of merchandise is unaffected by the government shutdown.  Outreach programs is an area have been affected by the lack of funds.

APHIS

APHIS is only accepting select permits- Permits 525, 526, 546, 585, 586, 587, 588, and 621 through its ePermits website.  USDA is not accepting mail at the current time so any permits sent through the mail will not be processed until the budget issue has been resolved.

EPA

EPA offices are closed.

Federal Maritime Commission

The FMC offices are closed. The FMC’s databases will not be accessible during shutdown.  The Commission’s website will be available during the shutdown but will not be updated until operations resume.  The Commission will not accept online filings or applications for Service Contracts, OTI applications or Tariff Registration Forms.  The Commission’s online databases will not be accessible.

Fish & Wildlife

The eDecs system is down due to the lapse in appropriations.  Therefore, all Fish and Wildlife documentation must be submitted in hard copy to the appropriate Fish and Wildlife office, including form 3-177.  Delays will likely occur in processing the documentation.

BIS

Bureau of Industry and Security (BIS) is no longer accepting license applications or classification requests

FSIS

FSIS will continue to operate as normal.

International Trade Commission

The website containing the Harmonized Tariff Schedule of the U.S. is not accessible.

For more detailed and live information please e-mail info@pharmafreight.com