The cGMP Requirement for Temperature Mapping is a mandatory requirement whenever regulatory controlled product is being manufactured, and thermal processing or storage is involved (heating or cooling). The individual Operational Qualification (OQ) of the equipment in use, must call for heat distribution; temperature mapping measurement studies of the actual heating or cooling process area used (Cabinet, Room or container). This temperature recording study must verify that all product will be subjected to the same thermal environmental conditions; no matter where the product is situated within the processing area, subjected to temperature mapping. This verification is mandatory and applies to all environmental process and storage equipment such as; mixers, ovens, freezers, hot rooms, cold rooms, sterilizers, warehouses, delivery vans, transport containers, stability chambers, freeze dryers and incubators.
During and after manufacture, the product is often held in storage areas or warehouses, it is essential that the temperature mapping of these storage areas is known to be within the specific requirements for safe storage of the product. It is therefore obvious that all these areas require temperature mapping to establish; by way of, documented evidence that the said storage area's are safe for the storage of environmental sensitive product.
The environmental conditions in these facilities are traditionally held to human comfort levels and that is purely within the physical level; humans are comfortable working within. Large fabricated metal storage warehouses can show enormous variations in both heat gains and heat losses. They can in certain locations and certain seasonal times hit highs of plus 60 degrees centigrade and lows of minus 30 degrees centigrade. This renders it essential to ensure your validation performance qualification (PQ) verifies; by way of, extensive temperature mapping, that during these extremes of temperature your product is maintained within the temperature range specified by the product makers.
Heat distribution and temperature mapping studies of large stores and warehouses requires sensors to be fitted strategically throughout the storage shelving, covering a percentage of the shelving area horizontally and vertically. A typical layout for a 1000 Square meter (floor area) warehouse with shelves stacked 4 meters high (giving 4000 cubic meters of storage area); would be one sensor in each corner of the storage area, one midway along each wall and one in the center. This means nine sensors would be placed on the lowest storage shelf, then nine on the middle shelf and finally nine on the top shelf; a total of 27 sensors.
Smaller processing equipment such as; stability chambers, ovens, incubators and autoclaves should be scaled similarly, with one sensor in each corner and one high layer and one lower layer, giving a total in a smaller volume of eight sensors. With an autoclave it is required to place an additional sensor in or close to the drain. Do not insert it down the drain, as it will fail. Remember you are required to demonstrate that climatic condition are uniform throughout the usable product processing areas - down the drain is not such an area.
Temperature mapping data The use of individual self contained data loggers that measure 1.06" x 3.7" (27mm x 94mm) and have the capacity to log 16,382 temperature points, makes the temperature mapping task much simpler. Logging at one record every 12 minutes gives a time scale of generating records continuously for over 200 days, or 45 hours at one every 10 seconds. The data loggers listed below are used by ourselves for temperature mapping and represent a quantum leap from the troublesome and very expensive, chart recorder days. It is really so simple to place the individual data loggers in place with no power or instrument wiring to obstruct everyday activities in the area. In fact the operators really do not notice that temperature mapping is taking place. At the end of the data logging exercise, the individual loggers are plugged straight into the laptop USB port, and the raw data down loaded. Since this temperature mapping is data that is printed out, reviewed and approved as hard copy, 21 CFR Part 11 does not apply.
Data logger configuration software suitable for temperature mapping is supplied, allowing the user to easily set-up the data logger. Selectable parameters include logging rate, measurement units, high & low alarms and start-time. The logged data stored in USB-Data Logger is downloaded via the configuration software. Once downloaded, data can be graphed, printed, or exported to other applications. The data logger configuration software is compatible with Windows 98/2000/XP.
The introduction of these self contained data loggers has transformed the task of temperature mapping. No longer do you have to pull fridges, freezers, cold or hot rooms out of service, to carry out temperature mapping of them, no longer do you have to fit expensive chart recorders to obtain process records of temperature mapping, no longer do you have to drill and fabricate bracket for recorders, sensors and power supplies. Just open the door and position a data logger among the load. For Operational Qualification, locate several (depending on volume to be logged) data loggers in the product area along with the product and preferably during routine production. For product records maintain one data logger permanently in the product area. Schedule the data longer for down loading every batch / month / quarter / year. Schedule the data logger for an annual battery change (it will not lose its records due to a flat battery or during battery change). The temperature mapping software is equally easy to use and comes free, with the data logger.
Validation Risk Assessment template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation risk assessment template.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
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 risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ 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; The User Requirements Specification template
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.
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (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 template. 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 current Good Manufacturing Practice use medical device use or a simple installation qualification template.
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, along with the installation qualification template.