TEMPERATURE SAFE TRANSIT



Temperature Safe Transit Rationale.

Temperature Safe Transit: Climatic conditions can be extremely challenging for operators charged with delivering temperature sensitive pharmaceutical product.  However just recently it has been highlighted just how deleterious extremes of temperature can be to drug efficacy. It has been demonstrated that with certain drugs a few hours soaking at temperature just 20% outside of the stipulated 2 to 8 degree centigrade; cold chain requirements, can result in a 25% reduction in drug efficacy. Whilst a shorter more extreme transgression can actually render the drug inert. Adding to these problems is the fact that the relationship between efficacy and temperature is probably unique to each individual drug.

Let us now define the temperature range within which we have to work. Recently temperature recorders were installed in the cargo sections of a range of delivery vehicles. These vehicles were engaged in routine delivery tasks across North America. The table below charts out a synopsis of the temperature encompassed, along with soak times at certain extremes of temperature.


North American Regional Temperature Extremes.

Cold Season

Regions

Minimum Temp

Duration below 10C

Duration Below 0C

Eastern

-11.5C

7.7 Hours

32.3 Hours

Western

-19.8C

38.0 Hours

89.5 Hours

Southern

-10.8C

0.7 Hours

41.3 Hours

Hot Season

Regions

Maximum Temp

Duration Above 40C

Duration above 60C

Eastern

46.0C

12.2 Hours

Zero

Western

60.9C

39.3 Hours

2.3 Hours

Southern

45.9C

13.7 Hours

Zero


Temperature Safe Transit Transport Implications.

Three words that are beginning to have a lot of significance.  Clinics around the world are now reading horror stories regarding vaccines that were silently and irreversibly damaged during storage and or transportation; when none-validated temperature controlled transport and storage facilities were utilized.  Now the regulators are demanding that documented temperature history must be available for all temperature sensitive regulated product; from manufacture to enduser.
  This is the much debated "Cold Chain" and it is with us to stay. The regulations are now in place for all to view, so do not be surprised when you are asked to produce them.  In the UK thousands of people are being re-injected to try and ensure protection.  What will happen when a protected person becomes infected by the very infection they are supposed to be.


Temperature Safe Transit - Approved Transportation Providers

A pictoreal presentation of an form of Temp Safe Transit transport.

According to a recent study conducted by the U.K. - based Medicines and Healthcare Products Regulatory Agency (MHRA), a staggering 43% of critical and major product deficiencies are related to ineffective temperature safe transit transport problems and or monitoring during storage.

Similarly the World Health Organization (WHO) recently maintained that 25% of all vaccine products arrive at their final destination in a degraded state.  Given the high cost of conducting global clinical trials and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain - transportation and logistics providers included − conform to GxP guidelines.

FDA’s “cGMP / 21 CFR 211”

WHO’s “Good distribution practices for pharmaceutical products” and “Guide to good storage practices for pharmaceuticals”

Canada’s “Guidelines for Temperature safe transit - Control of Drug Products during Storage and Transportation”

Ireland’s “Guide to control and monitoring of storage and transportation temperature conditions for medicinal products and active substances.

”EU’s “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” (94/C 63/03)


The Positioning Of The Data Loggers.

The number of individual data loggers that are required to guarantee temperature safe transit and their exact positioning within the vehicle load area has been rationalized as;
40 foot standard container: Requires 15 individual data loggers. Comprising four strings of three. Each sting running lengthways; two positioned 6 inches from the floor and 6 inches from the - sidewall each side. Similarly two strings positioned 6 inches from the roof and 6 inches from the - side walls each side. The remaining one to be fitted at the centre point of the container volume.

20 foot container: Requires 9 individual data loggers. Comprising of four strings of two. Each string running as the strings for the 40 foot container. The remaining one to be fitted at the center point of the container volume.
10 foot container: Requires 8 individual data loggers. . Comprising of four strings of two. Each string running as the strings for the 40 foot container. No center one is required.

If there are disruptive influences to the general air in /out flows or to the location of the conditioned air inlet and or exhausts then these location would have to be altered and would possibly have to be establish by conducting preliminary container airflow mapping flow study. However when the position and number of sensors has been agreed, the justification for your choice of sensor location for temperature safe transit temperature mapping validation must be documented in the Validation Plan.



TEMPERATURE SAFE TRANSIT.



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.



Cold Chain Validation Package level-1 (Issue 3) $575.00
12000396

This is the common document package that is sent out with all our Cold Chain Validation Packages. It contains five documents that make up the advertised document package. No matter what your validation requirements are these documents will guide you through the task. No matter whether you are to validate a cold container or a mobile cold cabinet or a vehicle integral container or smaller service van. In all these cases you require the Validation Plan (VP) to detail the what, where, how and who of your task. Then the Validation Risk Assessment (VRA) to define your task. After this, the standard flow of documents is required - Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). All of these documents are mandated by cGMP's. There are no short cuts to compliance.

VP, VRA, IQ, OQ, PQ.

This package contains one of each of these documents, but no data loggers. The end user has to supply a means of capturing all the transient temperature data.

Quantity

Cold Chain Validation Package Level-2
$1160.00
12000397

The content of this package includes the document pack as detailed in Level 1 above. Plus quantity 10 off, single channel data loggers. Simple and robust to use. This is now the simplest, most expedient and cost effective method of validating the climatic condition within any mobile container or vehicle body.

VP, VRA, IQ, OQ, PQ.

This package contains one of each of these documents. Plus 10 off single channel data loggers and is sufficient to validate a volume of 8 (cubic metres).

Quantity

Cold Chain Validation Package Level-3
$2575.00
12000398

The content of this package includes the document pack as detailed in Level 1 above. Plus quantity 20 off, single channel data loggers. Simple and robust to use. This is now the simplest, most expedient and cost effective method of validating the climatic condition within any mobile container or vehicle body.

VP, VRA, IQ, OQ, PQ.

This package contains one of each of these documents. Plus 20 off single channel data recorder and is sufficient to validate the volume in a standard 20 foot (38 cubic metres) container.

Quantity

Cold Chain Validation Package Level-4
$3966.00
12000399

The content of this package includes the document pack as detailed in Level 1 above. Plus quantity 30 off, single channel data loggers. Simple and robust to use. This is now the simplest, most expedient and cost effective method of validating the climatic condition within any mobile container or vehicle body.

VP, VRA, IQ, OQ, PQ.

This package contains one of each of these documents. Plus 30 off single channel data loggers and is sufficient to validate the volume in a standard 40 foot (77 cubic metres) container.

Quantity