DATA LOGGER.
The cost effectiveness of logging data.
Data logger numbers and locations required for successful warehouse climatic mapping is governed by several factors, disruptive air flow entering or leaving the storage area, distribution of conditioned air inlet and exhausts, open doorways and or windows and generally the environmental insulation to walls and ceilings. A typical layout for 1000 square metre warehouse climatic mapping with shelves stacked 4 metres high; good general wall and roof insulation; no open doorways or windows and evenly spaced-out condition-air inlets and exhausts, could be one sensor in each corner of the storage area, and one midway along each wall, with one in the centre. 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. Smaller rooms could be scaled similarly, with one sensor in each corner and one high layer and one lower layer, giving a total in a smaller room of eight sensors. 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 warehouse climatic mapping air flow studies. However when the position and number of sensors has been agreed, the justification for your choice must be documented in the Validation Plan. Are you beginning to see just how important the Validation Plan is?
Data Loggers Specifications.
These data recorders measure and store up to 16,382 temperature readings over a -35 to +80°C (-31 to +176°F) range. The user can easily set up the logging rate and start-time, and download the stored data by plugging the module straight into a PC's USB port and running the purpose designed software under Windows 98, 2000 or XP. Data can then be graphed, printed and exported to other applications. The recorder is supplied complete with a long-life lithium battery, which will last for at least 1 year. Correct functioning of the unit is indicated by a flashing red, green and orange LEDs. The recorder is protected against moisture to IP 67 (Nema 6) standard when the protective cap is fitted. Software is included with each recorder.
Features and Specifications
- -35 to +80°C (-31 to +176°F) Measurement Range
- USB Interface for Set-up and Data Download
- 2 User-Programmable Alarm Thresholds
- Bright Red, Green and Orange LED Indication
- Replaceable Internal Lithium Battery
- IP 67 Protection (Nema 6)
- Internal Resolution: 0.5°C (1°F)
- Accuracy (overall error): ±1°C(±2°F)
- Logging rate: 10s, 1m, 5m, 30m, 1hr, 6hr or 12hr
- Battery life: 1 year typical
- Programmable start date and time
- Dimensions: 1.06" x 3.7" (27mm x 94mm)
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Validation Plan (Issue 8)
$89.00 10000008
This document follows our well developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facilities/utility equipment/ facilities HVAC using electronic controls or monitoring.
Validation Risk Assessment (Issue-11.) $125.00
10000014
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 activities.
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). Applies to all facilities HVAC protocols.
Top of Form Cold Chain Zone IQ (Issue 5)
The SOP used to generate this 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 for your temperature controlled cabinet or room. 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. This applies to all facilities HVAC protocols.
$115.00 10000401