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Utilities.

Validation Master Plan (Issue 7)
$115.00
10000001
This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. A great document to author and use. This document interfaces with our Validation Risk Assessment assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

Document Statistics

 Protocols = 1

Pages = 47 

Paragraphs = 945       

Lines = 1801 

Words =  9922 

 Characters = 66311

 Graphics = 15

 Size = 789 KB


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Validation Documentation Matrix (Issue 6.)
$29.00
10000002
This Matrix must sit along side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document, the A to D prefix shows the progress stage.
Please remember that this document is an Excel document, so when your download link arrives you must use Excel to open it


Quantity   
User Requirements Specification (Issue 7.)
$115.00
10000010
The document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. 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 URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.

Document Statistics

 Protocols = 1

Pages = 27 

Paragraphs = 481         

Lines = 1374 

Words =  2563 

 Characters = 18021

 Graphics = 14

 Size = 302 KB


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Design Qualification (Issue 4.)
$115.00
10000012
The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that youre DQs are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

Document Statistics

 Protocols = 1

Pages = 29 

Paragraphs = 634        

Lines = 1961 

Words =  3142 

 Characters = 19475

 Graphics = 19

 Size = 316 KB


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Validation Risk Assessment (Issue11.)
$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 categorising 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).

Document Statistics

 Protocols = 1

Pages = 18 

Paragraphs = 344         

Lines = 810 

Words =  341 

 Characters = 20084

 Graphics = 10

 Size = 179 KB


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Installation Qualification. SOP & Protocol (Issue 9.)
$115.00
10000020
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. 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. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.

Document Statistics

 Protocols = 1

Pages = 51 

Paragraphs = 1030     

Lines = 3240 

Words =  6006 

 Characters = 38541

 Graphics = 39

 Size = 581KB


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Operational Qualification, SOP & Protocol (Issue 10.)
$115.00
10000025
You will find the step by step attached SOP 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 Operational Qualification Protocol. 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.

Document Statistics

 Protocols = 1

Pages = 40 

Paragraphs = 664      

Lines = 2291 

Words =  4571 

 Characters = 28586

 Graphics = 23

 Size = 397 KB


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Performance Qualification (P1Q) (Issue 5.)
$89.00
10000027
The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it somtimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.

Document Statistics

 Protocols = 1

Pages = 21 

Paragraphs = 219          

Lines = 982 

Words =  2532 

 Characters = 13840

 Graphics = 8

 Size = 204KB


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Process Qualification (P2Q) (Issue 3.)
$85.00
10000028

The Process Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorded and reviewed with a view to ensuring that the deviances (within permitted tolerances) that exist are random and not a trend that could lead to out of specification produce being produced.

Document Statistics

 Protocols = 1

Pages = 21

Para = 321  

Lines = 984 

Words = 2597

 Char = 13978

 Graphics = 9

 Size = 204KB


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Package for Equipment Validation Level-1. (Issue 3)
$465.00
10000101
Level One.
You want to execute the minimum paperwork to qualify an item. Start with a VP because it is mandatory. Raise a URS because it also is mandatory. Raise a VRA because it is mandatory in risk based validation. Execute all tests and inspections using a combination IQ-OQ-PQ. This is a balance approach and covers the mandated regulatory requirements. To be used within a facility that is fully validated and subject to change control.
Just to recap in this case you require the following validation protocols;
VP, URS, VRA, IQ/OQ/PQ.
Level 1 Package consists of one of each of these documents.

Document Statistics

 Protocols = 4

Pages = 141 

Paragraphs = 2649        

Lines = 8476 

Words =  18316 

 Characters = 100580

 Graphics = 135

 Size = 2867KB


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Package for Equipment Validation Level-2. (Issue 3)
$585.00
10000102
Level Two.
You want to validate a process line or new process equipment or individual process assembly stage equipment or just similar equipment that has equipment that has been subjected to major modification.
In this case you require the following validation protocols :-
VP, URS, VRA, DQ, IQ, OQ, PQ.
Level 2 Package consists of one of each of these.

Document Statistics

 Protocols = 7

Pages = 215 

Paragraphs = 4060       

Lines = 12000 

Words =  24726 

 Characters = 184757

 Graphics = 125

 Size = 2755KB


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Package for Equipment Validation Level-3. (Issue 4)
$695.00
10000103
Level Three.
You have a new installation or refurbished installation or piece of equipment and you want to establish the correct validation documentation.
In this case you require the following validation protocols:-
VMP, VP, URS, VRA, DQ, IQ, OQ, PQ.
Level 3 Package consists of one of each of these documents.)

Document Statistics

 Protocols = 8

Pages = 262 

Paragraphs = 5005         

Lines = 13794 

Words =  34658 

 Characters = 241068

 Graphics = 140

 Size = 3096KB


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10000149_PQ_Steam (Issue 2.)
$115.00
10000149
Steam Quality Validation. This a high quality protocol listing all component parts that required for setting up and executing of the three main steam quality tests. All the operator has to do is use the auto fill function to personalize the PQ, then follow through the detailed test methods recording the results as they go.
A continuous supply of saturated steam is required for steam sterilization. Too high a level of non condensable gases will prevent the attainment of sterilization; too little moisture carried in suspension may allow the steam to become superheated during expansion into the chamber, while excess moisture may cause damp loads. Where steam systems are either routinely or irregularly shut down, large quantities of air will be present in the distribution system on restarting. It is recommended that in such circumstances a comprehensive and validated venting procedure should be applied, and testing of steam quality is mandatory.


Quantity   
Facility_Combined_IQ-OQ_Issue-2
$125.00
10000501

This Combined IQ OQ protocol is a really easy and attractive document to use.  It is prefaced by a 10 page SOP, which enables you to follow the SOP instruction and progressively (page by page) convert this fully detailed template into a superb IQ/OQ protocol.

 

This protocol is targeted at equipment and is suitable for all equipment from the laboratory to the process line.  All standard verifications are already included in the protocol format with many more testscripts that can be edited in or out to tailor your IQ/OQ protocol exactly to your regulatory requirements.

This new combined IQ OQ protocol brings a refreshingly simple and attractive approach for the industry professional to raise professional quality validation protocols in a most cost effective way.


Quantity   
Package Water System Validation. (Issue 1)
$675.00
10001090
It is required that all pharmaceutical pure water systems are subjected to sufficient tests and inspections to verify and document that the system is installed, operating, and performing as per the user requirements, prior to production handover. Validation documentation is made up of the following components:
This Validation Package contains: VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Quantity   
Quality Water DQ (Issue 3)
$115.00
10001095
You will find the step by step attached SOP delightfully simple and straightforward to use, as it takes you through the process of customization of your Design Qualification template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific Design Qualification.

Document Statistics

 Protocols = 1

Pages = 40 

Paragraphs = 664      

Lines = 2291 

Words =  4571 

 Characters = 28586

 Graphics = 23

 Size = 397 KB


Quantity   
Quality Water IQ (Issue 2)
$115.00
10001096
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. 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. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.

Document Statistics

 Protocols = 1

Pages = 51 

Paragraphs = 1030     

Lines = 3240 

Words =  6006 

 Characters = 38541

 Graphics = 39

 Size = 581KB


Quantity   
Quality Water OQ (Issue 2)
$115.00
10001097
You will find the step by step attached SOP 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 Operational Qualification Protocol. 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.

Document Statistics

 Protocols = 1

Pages = 40 

Paragraphs = 664      

Lines = 2291 

Words =  4571 

 Characters = 28586

 Graphics = 23

 Size = 397 KB


Quantity   
Quality Water PQ (Issue 2)
$85.00
10001098
The Process Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification produce being produced.

Document Statistics

 Protocols = 1

Pages = 21 

Paragraphs = 321           

Lines = 984 

Words =  2597 

 Characters = 13978

 Graphics = 9

 Size = 204KB


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SOP for Quality Steam Testing.
$499.00
10010151

This is a fully documented and detailed SOP that you will use every time you execute your periodic re-qualification of your quality steam system(s) Tests scripts are very detailed and all calculations are broken down into simple stages Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician. The main reason people have traditionally contracted steam-quality-testing-out, was that the hardware (pitot and expansion tubes) were extremely difficult to obtain. We have had these manufactured for our own use and include them in this offer. All other test equipment required is readily available in most laboratories (tubing, glassware and multi-meter). This SOP is an absolute must for companies that want to be certain that their sterilization processes are never compromised.
Price of kit includes expansion and pitot tubes.


Quantity   
Verification of Lubricants (Issue 2.)
$16.00
11000162
Test sheets used in Installation Qualification Protocol to verify that all CFR requirements concerning lubricants, construction and use, have been implemented and are being complied with. Comes with standard IQ, but available separately here.


Quantity   
21 CFR Part 11 Eligibility Verification (Issue 3.)
$16.00
11000163
Test sheet used in the operational qualification protocol to document and record whether the equipment produces data that necessitates compliance with 21 CFR Part 11. This document is included in the standard OQ, but available separately here.


Quantity   
21 CFR Part 11, Verification (Issue 3.)
$26.00
11000164
This test script has been designed to verify whether a system or a specific piece of equipment conforms with the requirements detailed in Part11. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.

Quantity   
Analog Address Verification (Issue 3.)
$16.00
11000165
Analog Loop address verification. This confirms and documents that that the computer input specified in the system specification of the loop is correct. A mandatory part of system validation. This document is included in the standard IQ, but available separately here.


Quantity   
Analog Loop Tests (Issue 3.)
$16.00
11000166
Analog Loop testing. This confirms and documents the integrity of the entire loop, and is a mandatory part of validation of system. Only available here as a paste in addendum to the Installation Qualification.


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Application Software Identification Verification (Issue 2.)
$16.00
11000167
Test sheet used in the operational qualification protocol to document and record the issue level, date of issue and title of the application software that the equipment under qualification has installed during execution of this operational qualification. This document is included in the standard OQ, but available separately here.


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Cabinet Temperature Mapping (Issue 4.)
$16.00
11000169
This test script is used to verify that whenever product is stored or processed at a specified temperature, within a enclosed area, all of the product is subjected to the same temperature and that the temperature at all times remains within the process specified limits.

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Change and Consumable Parts Verification (Issue 3.)
$16.00
11000170
This test verifies that the change and consumable parts that are required to operate and maintain this equipment in its validated status are available to the operators. It is standard in the basic Installation Qualification, but available here as a separate download.


Quantity   
Critical Area Material of Construction Verification (Issue 1.)
$16.00
11000171
Test sheets used in Installation Qualification Protocol to verify that all system product contact parts are manudfactured from a suitable material. Comes with standard IQ, but available separately here.


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De-ionizer Unit Regeneration Test (Issue 1.)
$16.00
11000172
Quality of the de-ionized water is continually monitored by a conductivity meter. When water quality falls to a preset limit during service, the conductivity controller in the de-ionizer unit automatically shuts the input solenoid valve isolating the water supply. This indicates that the resins are approaching exhaustion and require regeneration. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.


Quantity   
System Drawing Verification (Issue 2.)
$16.00
11000172
Test sheets used in Installation Qualification Protocol to verify that the engineering drawings are as required in 21 CFR. Comes with standard IQ, but available separately here.


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Electrical Conformance Verification (minor) (Issue 3.)
$16.00
11000173
Test sheets used in Installation Qualification Protocol to verify that the system electrical installation conforms to good industry standards. Comes with standard IQ, but available separately here.


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Equipment Function Test (Issue 1.)
$16.00
11000174
Test sheets used in the operational qualification protocol to review and comment on a completed function test schedule, which has been used to verify the functionality of the equipment under qualification. This document is included in the standard OQ, but available separately here.
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Input Output Address Verification (Issue 3.)
$16.00
11000176
Input output address verification is mandatory, and is executed to document and verify that the computer input output address configurations is in accordance with the drawing specifications. Only available here as a paste in addendum to the Installation Qualification.


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Pipe Work Record Tests & Inspections (Issue 3.)
$16.00
11000179
Test sheets used in Installation Qualification Protocol to verify that all system pipe-work is installed in accordance with the drawing and specification. Not included in standard IQ. Only available here as a paste in addendum to the Installation Qualification.


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Power failure Test (Issue 3.)
$16.00
11000180
Test sheet used in the operational qualification protocol to document and verify that when the equipment is subjected to an unintentional loss of electric supply it will fail and be reinstated in a manner save to the product and operating personnel. This document is included in the standard OQ, but available separately here.


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Quality Water Alarm Test (Issue 3.)
$16.00
11000181
When water quality falls to a preset limit during service, this conductivity sensor will automatically go into an alarm condition. It is required in this protocol to demonstrate that this operates and to record the level it activates and deactivates at. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.


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Process Valves Records Of Tests & Inspections (Issue 6.)
$16.00
11000182
Process Valves Records of Tests and Inspection, consists of mandatory tests and inspections that are requires to be executed and documented in the verification that all the listed valves conform to their respective drawing specification. Only available here as a paste in addendum to the Installation Qualification.


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Operating System Software Verification (Issue 3.)
$16.00
11000183
Test sheet used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Included in standard OQ, but available separately here.
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HEPA Filter Clean PD Correction (Issue 3.)
$26.00
11000184
In a non compensating HEPA flow regime a dirty filter will progressively reduce the room airflow. This can resultant in insufficient air flow to protect staff and or the product, it can be dangerous for both. If you started with an actual flow that was only 40% of the rated flow, the filter would be seriously blocked before you reached the un-corrected dirty filter change PD. This is why regulators will ask for the filter clean DP justification calculations.

The manufacturers dirty filter change pressure differential (PD), is only correct if the filter is used at exactly the the same air flow as the makers specify. If there is any digression (there is often as much as 50% digression) then the makers PD must be corrected. If this is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This test script is not in the standard OQ, and is only available here as a download.


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Radio Frequency InterferenceVerification (Issue 5.)
$16.00
11000185
Test sheet used in the operational qualification protocol to document and verify that when the operation of equipment will not be adversely affected by the use, near by, of radio emitting devices. This document is included in the standard OQ, but available separately here.


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Safety/Health/Environmental Assessments (Issue 2.)
$16.00
11000187
There are several Health, Safety and Environmental assessments that must be carried before an item of equipment is put into service. This test script ensures that they are all in place and available for review. This document is not included in the standard operational qualification, but is a available here as a direct download.


Quantity   
Security of Back-up Software (Issue 3.)
$16.00
11000188
It is mandatory that where software has to be validated, there is a certified true copy, of that software stored in conditions laid down by cGMP's. This test script verifies that these conditions are being met. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.


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Sensor Calibration Verification (Issue 3.)
$16.00
11000189
Test sheets used in Installation Qualification Protocol to verify that all system sensors requirements as detailed in 21 CFR, are complied with, comes with standard IQ, but available separately here.


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System Component Verification (Issue 2.)
$16.00
11000191
Test sheets used in Installation Qualification Protocol to verify that the system components are installed correctly and that the installation is documented as detailed in 21 CFR. Comes with standard IQ, but available separately here.


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System Documentation (SOP) Verification (Issue 3.)
$16.00
11000192
Test sheet used in operational qualification to verify that all the SOP requirements in CFR 21 for this type of equipment are in place and are approved company documents. Included in the standard OQ, but available separately here.


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System Documentation Verification (Issue 3.)
$16.00
11000193
Test sheets used in Installation Qualification Protocol to verify that the equipment documentation is as required in 21 CFR. Comes with standard IQ, but available separately here.


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System Future Maintenance Verification (Issue 3.)
$16.00
11000194
Test sheets used in Installation Qualification Protocol to verify that post qualifiction maintenance of system is adequate and complies with 21 CFR requirements. Comes with standard IQ, but available separately here.


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Test Equipment Calibration Verification (Issue 6.)
$16.00
11000195
Test sheet used in the operational qualification protocol to document and verify that all test equipment and sensors used in the execution of the operation qualification are calibrated, and have traceable calibration standards. This document is included in the standard OQ, but available separately here.


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Verification of Password Controlled Access (Issue 2.)
$16.00
11000197
It is required to verify in this test script that access to the equipment is controlled by the use of passwords, and that the passwords are graded to allow access only for their authorized job functions. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.


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Verification of Vessel Installation (Issue 3.)
$16.00
11000198
Verification of Vessel Installation, covers all the installation details that must be verified to confirm that the vessel is installed in accordance with the drawing specification.Only available here as a paste in addendum to the Installation Qualification.


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Water Velocity Test (Issue 3.)
$16.00
11000199
Water velocity through the distribution loop should be maintained within set parameters. Correct speed above ensures adequate scavenging of dead legs takes place. To high a speed induces excess turbulence which inhibits scavenging. It is required in this protocol to confirm that the water velocity is correct. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.


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Humidity Calibration Kit.
$649.00
112340
Humidity sensors require frequent calibration and continual monitoring, they are, along with pH sensors, the most prone to error sensors; in general facility use. Where as most sensors measure to within (plus or minus) 1% and have extremely low drift rates. Competitively priced humidity sensors measure to within (plus or minus) 3% at mid range and 5-7% at the top and bottom of their ranges, and have a significant drift rate.
The kit includes three ready to use saturated salts solution enclosures each with certification of their values. A range of adaptors to suit your various sensors sizes. A sample FDA compliant calibration certificate and a complete detailed method statement on exactly what to do. All these items are contained in a robust neat and easy to handle carrying case. All ready to start calibrating. For further technical details please click here
Your Humidity Calibration Kit (112340) should be returned annualy for refreshment of the saturated salts solution, calibration and re-certification.

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