Medicinal products require controlled storage and transit conditions in order to ensure that their quality is not compromised. This applies to low-risk products as well as high-risk products such as vaccines, insulin’s and blood products (such as Factor VIII), which normally require storage between2°C and 8°C. All distributors of drug products are required to record storage and transportation temperatures, as well as being licensed by the appropriate authorities. Temperature monitoring devices should be used to demonstrate compliance with the records that are kept.

The pharmaceutical distribution chain
At every point in the chain, precautions should be taken to minimise the effect of external conditions on the quality and stability of the product. It is mandatory that records should provide reliable up-to-date evidence of compliance, in case of audits and investigations from the MHRA and other stakeholders. Before setting up a storage facility, transport system or taking on a new range of products it is advisable that distributors carry out a risk analysis.

Introduction
Medicinal products require controlled storage and transit conditions in order to ensure that their quality is not compromised. This applies to low-risk products as well as high-risk products such as vaccines, insulin’s and blood products (such as Factor VIII), which normally require storage between2°C and 8°C. All distributors of drug products are required to record storage and transportation temperatures, as well as being licensed by the appropriate authorities. Temperature monitoring devices should be used to demonstrate compliance with the records that are kept.

This guide offers you knowledge and advice on best practice throughout the distribution chain, including storage and transportation.
Cold storage
Low volume
Domestic refrigerators may be suitable for cold storage of small volumes of some products, for example eye drops, which require cold storage but are less susceptible to being out of the recommended temperature range.
Domestic refrigerators:
• Are generally not suitable for high-risk products
• May not have the precise electronic control necessary to maintain the temperature within the range 5°C±3°C
The minimum requirement for monitoring is a max/min thermometer. This should be placed within the load and positioned so that opening and closing the door will not affect the readings. The thermometer should be read and reset daily and the maximum and minimum temperatures recorded. Care should be exercised when placing goods in domestic units. If placed next to or in contact with the chiller plate or coil, their temperature may fall below the recommended minimum. Because domestic refrigerators lack the precise temperature control and uniformity, continuous recording should be considered. Thermal mapping is also advisable to determine cold and warm locations over a period of time.
High-risk products
• The refrigerator must be capable of maintaining the temperature of its contents between 2°C and 8°C throughout its volume, with the minimum of intervention
• Temperature monitoring should be performed by an electronic max/min thermometer with an accuracy of + 0.5°C, and should be readable from outside the refrigerator. Continuous, independent, recording with alarms would normally be advised
• It is advised that the thermometer should have a battery back-up (if mains powered) so traceability of product temperature can be maintained should the power fail
• The probe should be placed within the load (or within a suitable buffer) to record the load rather than the air temperature, and the max/min temperatures should be recorded daily to ensure that the refrigerator remains within its specifications

• The device should be calibrated annually against a certificated thermometer and should be temperature mapped
• The unit should have an auto-defrost facility and the temperature of product within the unit should not fall outside defined limits during the defrost cycle
• Refrigerators should be sited in an environment where the ambient temperature does not affect the temperature control within the unit. This normally means an external environment of between 10°C and 32°C
High volume
Large refrigerators (in excess of 6 m³) and walk-in cold rooms used in high-volume operations should be fitted with an electronic temperature-recording device that measures load temperatures. The chart, printout or direct reading should be checked daily and the examination recorded, either in a logbook or by annotation of the record chart or print-out. The use of electronic recorders should be considered.
• The facility should be fitted with a power-failure alarm
• Portable data-loggers, which can be downloaded onto a computer, may be used instead of a fixed device, though the system should allow temperatures to be seen/alarmed at all times
• The internal air temperature distribution should be mapped on installation in both the empty and full state. Air temperature distribution should be checked annually under conditions of normal use
• External conditions should be taken into consideration during mapping
• The recorder probe should be placed within the load for routine monitoring and if air distribution is not fan-assisted the probe should be located in the part of the load at the highest risk from low temperatures. Consideration should be given to the use of multiple probes placed as required with reference to the temperature mapping results
Walk-in units
• Temperature mapping should be repeated if significant changes take place, such as the repair or replacement of the refrigeration unit or changes to the internal storage layout
• A calibrated max/min thermometer should be placed inside the unit for use as a back-up and to confirm the temperature indicated on the recorder
• Goods sensitive to temperatures greater than 8°C should not be stored next to the door and goods susceptible to temperatures below 2°C should not be placed in the airflow from the refrigeration unit
• Probes should be sited within an appropriate load simulator so that transient rises in temperature (such as might occur when a door is opened) do not trigger the alarm
• The low-temperature alarm must trigger before the temperature drops below +1°C
• Condensate from chiller units should not be collected inside the cold store in an open vessel
• Consideration can be given to the monitoring of relative humidity (RH) within the facility
• Large refrigerators and walk-in units should be subject to regular (at least annual) servicing

Freezers
A small but increasing number of products must be stored frozen (e.g. some blood products and products of biotechnology). These will be labelled store below -5°C (freeze) or below -15°C (deep freeze) or they may show a range (e.g. -15°C to -20°C). Storage units must be capable of maintaining the required temperature in all parts of the load, and temperatures should be monitored within the load and recorded daily.
Transporting products that require low-temperature storage
The type of shipping system will be decided by the load size, the nature of the product, the risk presented by high and low temperatures and fluctuations, and the time of exposure to adverse conditions.
• Bulk cold-chain goods should preferably be shipped in refrigerated transport
• Refrigerated vehicles are appropriate for distribution of smaller consignments of high-risk goods, such as vaccines; temperature should be strictly monitored
• Temperature-stabilising materials should be chosen with care. Dry ice should not be used in shipping rubber-stoppered vials because the low temperature may lead to shrinkage of the rubber
• Refrigerated vehicles should be fitted with continuous recording devices, or a number of portable monitoring devices may be placed within the load
• The number of temperature monitors will depend on the size of the load and they must be located carefully to ensure temperatures in all parts of the load remain acceptable
• The temperature gradient within a large load can vary significantly from outside to middle
• Shipping companies and distributors should review temperature records for each consignment and have a procedure in place for implementing corrective action in the case of adverse events
• For smaller consignments transported by road in individual thermal containers, where transit times are measured in hours rather than days, it may be possible to rely on validation data supported by occasional temperature monitoring of deliveries
• Distributors should ensure that recipients of cold-chain goods are aware that the consignment contains goods which require special storage conditions
• Suppliers should indicate clearly on the packaging both when the product was removed from cold storage and when it must be placed back
• The consignee is advised to satisfy himself that the goods have not been subjected to adverse conditions during transit. For example, by viewing a printout from a data logger or monitoring device placed in the load by the consignor
• Consignors should provide a clear diary of the journey
Returns
Returns of high-risk goods should be accepted for reissue only if the customer notifies the distributor of the error immediately on receipt of the goods, and it can be demonstrated the goods have been held under suitable conditions (e.g. by signed copy of a recorder chart).
Returns of lower risk goods may be acceptable, provided that they are made promptly and that it can be established that they have not been outside cold storage for a total of more than 24 hours.
Cool storage
A small number of medicinal products are labelled ‘store in a cool place’ or ‘store between 8°C and 15°C’. If a facility operating within this range is not available, advice is that the goods may be stored at 2°C-8°C, provided that storage below 8°C does not affect their physical stability. Otherwise they should be stored in the coolest part of the warehouse and temperature monitoring should be regularly carried out.
Controlled room temperature storage
Unless stated otherwise, the majority of medicinal products can be stored under conditions of controlled room temperature. These products are usually labelled ‘do not store above 25°C’. For these products room temperature extremes of hot and cold temperature must not be encountered.
The minimum requirement for temperature measurement is that a max/min thermometer be placed at a strategic location and read, recorded and reset regularly and measured at both low and high levels. During periods of exceptionally hot or cold weather the frequency of monitoring should be increased. Warehouses should be temperature mapped to determine the temperature distribution.
Mapping should be repeated every 2-3 years and after any significant modification to the premises, stock layout, or heating system. Heat gain of goods stored next to sun-facing windows, at high level in poorly insulated stores, or next to heaters, should be considered.
Mean Kinetic Temperature
MKT is a calculated fixed temperature that simulates the effects of temperature variations over a period of time. It expresses the cumulative thermal stress experienced by a product at varying temperatures during storage and distribution. Good warehousing and distribution practice requires that warehouse temperatures are controlled and monitored and that appropriate action is taken if temperatures exceed the storage conditions stated on product labels.
• Strict conditions should be applied to the use of MKT
• It is applicable only to the storage of products under controlled room temperature conditions, such as those labelled ‘do not store above 25°C’
• The application of MKT should be described in a written procedure
• MKT should not be used to compensate for poor temperature control of storage facilities
• The calculation of MKT for the time that a product has been in storage can only be carried out off-line as any on-line calculation can only be for the entire storage facility
Calibration of measuring devices
Manual and electronic measuring and recording devices used in critical areas and with high-risk goods should be calibrated at least annually against a traceable reference device. Records should include pre- and post- calibration readings and details of any adjustments made.
Written procedures and records
Written procedures should be available to describe the control and monitoring of storage and transportation temperatures and the calibration of measuring devices. Procedures should include alert and action alarm limits and the procedure to be followed if the temperature falls outside these limits. The designated responsible person should review monitoring records independently, at least monthly, if this person is not involved directly with the day-to-day monitoring. This review should be recorded.
• Consider a risk assessment of the storage facilities
• Consider the number of monitoring points against volume and thermal mapping results
• Consider backup power supply to ensure continuous monitoring during power/plant failure
• Remember each storage facility requires to be temperature logged
• Consider the cost/benefit of continuous monitoring against manual recording
• Ensure that temperature recording remains valid with regular thermal mapping and instrument calibration
• Self inspections should be carried out and recorded
• Consideration can be given to the use of a central monitoring recorder with probes located at different facilities. A risk analysis should be performed
References:
MHRA Guidance Note No.6: NOTES FOR APPLICANTS AND HOLDERS OF A WHOLESALE DEALER’S LICENCE
Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products: John Taylor, CChem, FRSC.
MHRA website: www.mhra.gov.uk
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03):

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2001/may/gdpguidelines1.pdf

www.abb.co.uk Source

EU and UK legislation covers temperature control requirements during the storage
and transport of perishable foods. These regulations have been revised in early 2006
and regulation EC No 852/2004 on the Hygiene of Foodstuffs requires manufacturers
to have suitable temperature controlled handling and storage facilities that can
maintain food at appropriate temperatures and enable these temperatures to be
monitored controlled and recorded. There are also specific temperature requirements
for certain categories of food. Examples of specific temperature requirements for
chilled and frozen food products are given below. The UK has also
implemented specific chill temperature control requirements for foodstuffs not
covered by EC No 853/2004. These requirements apply to food which is likely to
support the growth of pathogenic micro-organisms or the formation of toxins. Such
food must be kept below 8 ºC unless the manufacturer recommends otherwise, but
this must be based on well-founded scientific assessment of the safety of the food at
the specified temperature.
There are also very limited chill holding tolerance periods where product may
be above the minimum but this must be consistent with food safety requirements, for
example during transfer from storage depot to transport vehicle.
The transport of perishable food products, other than fruit and vegetables, and
the equipment used for the carriage of these products is governed by an agreement
drawn by The Inland Transport Committee of the United Nations Economic
Committee for Europe in 1970-1971. The aim is to facilitate international traffic
by setting common internationally recognised standards. The agreement is known as
the ATP agreement and was adopted in the UK in 1980. It provides common
standards for temperature controlled transport vehicles such as road vehicles, railway
wagons and sea containers and sets down the tests to be done on such equipment for
certification purposes.

Transport temperature requirements of food products
Chilled products Temperature
(oC)
Fresh fish (in ice), crustaceans and shellfish (excluding live ones) +2
Cooked dishes and prepared foods, pastry creams, fresh pastries,
sweet dishes and egg products
+3
Meat and cooked meats pre-packaged for consumer use +3
Offal +3
Poultry, rabbit and gane +4
Non-sterilized, untreated, unpasteurised or fermented milk, fresh
cream, cottage cheese and curd
+3
Milk for industrial processing +6
Cooked meats other than those which have been salted, smoked,
dried or sterilized
+6
Frozen Products Temperature
(°C)
Ice and ice cream -25
Deep frozen foods -18
Fishery products -18
Butter and edible fats, including cream to be used for butter making -14
Egg products, offal, rabbit, poultry and game -12
Meat -10

Our kind friends at Volkswagen Northampton, kindly lent us a brand new Temperature controlled VW Crafter MWB for a trial.

The conversion has been carried out by one of the leading refrigerated van conversion companies Somers.

As promised we have some results regarding the overall performance of the vehicle and suitability for daily use by a refrigerated courier company.

The vehicle has been tested on a mixture of multidrop routes consisting of around 40 deliveries and a few long distance runs, so the findings are an average of the combined driving styles.

Temperature Controlled Performance

Overall we were extremely impressed with the conversion, comparing this to some other companies we would rate this as amongst the best we have seen and used.

The attention to detail with regards to the placement of the in cab electronics and pipes has been excellent, as seen from the pictures, it is important for the driver to be able  see the temperature control unit and the transcan 2 printout easily while driving to notice any issues. Many companies like to hide these away and do not realise the importance of having them visible to the driver.

The lining in the rear of the vehicle was also of an extremely high standard, great insulation to side and rear doors, the pallet protection was also well thought through as the picture below shows the bulkhead protection plate, (great use of a small slope in the lining to ensure maximum loading area whilst also protecting the buckhead). The only issue being the 3 strips of stainless steel which makes it easy to slide pallets in, but makes them move a lot in transit unless fitted with a load lock.

We have noticed many refrigerated van converters do not use the correct insulation on the rear or side doors for frozen operation, with Somers this is definitely not the case.

The fridge unit used was a GAH super rapier capable of operating to -25c. We find these particular units pull down to a minus temperature the quickest out of all we have tested so far on the market (for a large van). The unique direct air condenser mould used by Somers is a nice addition, creating a more aerodynamic look and also draws more air into the fridge unit reflecting it from the windscreen in road operation, which should result in an increased MPG and faster pull down time.

Starting the vehicle from +7c in normal road operation it took 27 minutes to reach -20c and 40 minutes to reach -25c (vehicle unladen).

Vehicle Performance

Very impressed with the overall handling and feel of this vehicle, brakes are responsive; suspension is hard which helps on cornering. The digital display on the dash lets you know when to change gear which is quite a nice touch. The stereo is basic and lacks Bluetooth connectivity.

After long periods of driving our drivers mentioned that the addition of an arm rest would add comfort. Good amounts of cup holders, and storage facilities which helps as they spend all day in the vehicle.

With the 2 litre engine VW have apparently eradicated the DPF issue which has plagued previous models, as the engine is working harder it can burn the fuel at a quicker rate than that of the 2.5litre versions. We saw no evidence of any soot or clearage issues on testing. However our 2009 models in our fleet have this problem when not used on long distance runs.

We managed to achieve a combined mpg of 22 miles per gallon, 67 litres of diesel roughly averages 307 miles running on -20c.

Payload 900kg

Pallet space x 3 standard

MPG 22

+7 to -20c 27 minutes

Rating 9/10

Verdict: Impressed with the conversion, it’s worth paying more for the quality of the insulation and finishing. The VW Crafter handles well and is a strong competitor to the Mercedes Sprinter, with the addition of 3 years unlimited mileage warranty from new makes this an extremely attractive offer for any courier or owner driver.

“Just some basic knowledge of how refrigerated vehicles work.”

Chilled and frozen products generally go through a number of storage and transport stages before
reaching the final consumer. The stages along the way must form a complete ‘cold chain’, with
products passing from one link to the next without any significant rise in temperature.

Freezer >Transport > Coldstore > Retail

Chiller > Distribution > Retail

Refrigerated Transport

Refrigerated transport

is just one vital link In this cold chain. Except in very rare circumstances, its job is not to cool products down, but only to keep them from warming up during the journey.

No matter how good it is, insulation cannot stop heat getting into a vehicle; it can only slow down the rate at which it gets in. As a general rule, the thicker the insulation is and the better it’s fitted, the more it will slow down heat penetration.

http://www.fresh-move.com

If you are looking to move some chilled or frozen goods within the UK, then make a start by visiting http://fresh-move.com an innovative company offering the best refrigerated courier services. All vehicles can be tracked live from your desktop, and temperature monitored at all times.

Let the Fresh Move team look after you consignment, all drivers are fully trained, and knowledgeable about the products they carry.
Fresh Move provides emergency refrigerated transport of food samples from some major food manufacturers, who rely on the critical nature of the temperature for testing purposes.
There is no need to jeopardise your products integrity by choosing the cheapest method of transport for your goods. Fresh Move is a brand name service which has built its reputation upon customer satisfaction, from the first point of call at the office, down to receiving an instant proof of delivery with temperature details which is unique to this industry.

The drivers really do go the extra mile for customer satisfaction; they can also remove any unwanted boxes or trays after the delivery as to not clutter the site with unwanted boxes.

New technologies are always being trialled such as PDAs for the drivers and new temperature monitoring hardware, to ensure they stay ahead of the game in more ways than one.

Fresh Move is a specialist carrier without the premium pricing structure; a rate card can be issued for regular deliveries helping customers to budget, so they know exactly what they will be paying for.

Exhibitions and events companies prefer to choose fresh move as the drivers are known to be the most helpful, they have even been known to help put up tents, and organise storage at busy festivals, such as the V Festival and Glastonbury.
There are many refrigerated courier companies who provide a basic service, allowing their standards to slip by subcontracting all of their deliveries to owner drivers, this is where fresh move have surpassed the industry standard. All of their drivers are fully uniformed and trained; they carry full handling equipment to cope with any eventuality which may occur. All vehicles are under 4 years old and maintained on a regular basis to ensure hygiene levels are kept to their optimum.

If your company use refrigerated transport or refrigerated couriers please do not hesitate to contact fresh move for the most professional chilled and frozen delivery service.
To be part of the network please search for fresh move on twitter, linkd in and facebook.

Kukri Spartans

A team that was put together by now whiley veterans Sven and Ridgey the team has grown from year to year.

With what started off as a struggle to get a team of boys that had even played rugby, the Kukri Spartans are now being dubbed the team to watch in 2010.

With a 2nd place settlement at Dayz in May, and 1st place in Milton Keynes 7′s the Kurki Spartans are now looking to take their 2 squads onwards into the 7′s season.

The Kukri Spartans are a team that base their fundamentals on a good team spirit they play as hard off the pitch as they do on the pitch.

With many traditions as well as some of their own they are a well known team for having the messiest and loudest socials. Usually found donning the ‘Ponch-WHOOOA’ or the Spartan of the day charity jacket in any pub that will let them in.

Now in their 4th year the team have expanded to 2 squads, the Alpha’s and the Omega’s. Both teams of equal quality the Spartans down right refuse to call them an ‘A’ and a ‘B’….just because they usually are only beaten by each other.

The squads themselves are made up of boys that have been brought together for the love of the sport and friendships through University and playing at high academy levels. This bond has remained with them as they have grown and improved each year. Kukri spartans blog

Olney 7s

Olney Rugby Football Club is the most powerful club side in the Bedford, Milton Keynes, Northampton “triangle”, with a history dating back to 1877.
They offer a wide range of facilities for the players, spectators and their families. Whether you prefer your rugby to be social, old, coarse or spectacular, there is definitely a side here for you.

If you would prefer not to play and merely drone on about how good you were when you were younger, fitter and better-looking, please come down…. you will find yourself in good company! Olney 7s website

We now have a blog where we will post the latest news and information from the Fresh Move team, you will be able to comment on our posts and let us know your thoughts. Now you can view our tweets without leaving the Fresh Move website.

We have a contact form for quick inquiries for those who prefer, also a employment form for potential employee’s to send us there details and be automatically added to our database.

We have made many improvements and I think you’ll agree our website looks fresh and dynamic. We have much more to add to our website so keep checking back for updates.