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Facilities.

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.


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Package Clean Room Validation. (Issue 4)
$265.00
10000153
The important selection of validation document for validation of Clean Rooms or Zones. This Validation Package contains one of each of these documents:
IQ, OQ & PQ.
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Clean Room Facility IQ Issue-6
$115.00
10000154 Quantity   
Clean Room Facility OQ Issue-6
$115.00
10000156 Quantity   
Clean Room Facility PQ Issue-6
$89.00
10000158 Quantity   
Cold Chain Validation Package Level-2
$1,699.00
10000397

This package is suitable for rooms or cabinets up to 10 cubic meters and arrives complete with all the validation documentation you require to validate the temperature condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP), The equally well detailed User Requirement Specification (URS), the Validation Risk Assessment (VRA). The Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are ten, temperature easy to use data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone.

Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
10 off Temperature Data Loggers (Capacity 18k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 1 to 2 cubic meters. Compatible with a 10 foot Reefer or container

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Cold Chain Validation Package Level-3
$2,654.00
10000398

This package is suitable for rooms or cabinets up to 50 cubic meters and arrives complete with all the validation documentation you require to validate the climatic condition within a warehouse, room or a cabinet. Documentation includes our interactive and detailed Validation Plan (VP), the equally well detailed User Requirements Specification (URS), the Validation Risk Assessment (VRA) and the Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are twenty temperature data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select.
Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
20 off Temperature Data Loggers (Capacity 17k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 5 to 25 cubic meters. Compatible with a 20 foot Reefer or container


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234
$3,966.00
10000399
This package is suitable for rooms and or cabinets up to 200 cubic metres and arrives complete with all the validation documentation you require to validate the climatic condition within a warehouse, a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are thirty, temperature and humidity, highly accurate and easy to use data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select. This is now the simplest, most expedient and cost effective method of validating the climatic condition within any climatically controlled zone.

Contains:- VP, VRA, IQ, OQ & PQ.
30 off Data Loggers (Capacity 32k parameters).
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Package Climatic Zone Validation. Level-4 (Issue 3)
$475.00
10000424
If your requirement is to validate a cold / hot climate controlled cabinet or room that is used within a facility that is fully validated and subject to change control and you do not need to purchase temperature and humidity recorders, then this package comes without hardware.
In this case you only require the following validation protocols;
VP, VRA, IQ, OQ, PQ.
This package consists of one of each of these documents.

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Facility URS (Issue-3)
$115.00
10000500
This is 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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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.


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Facility VMP (Issue-3)
$115.00
10000505
This Facility Validation Master Plan FVMP 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 = 32 

Paragraphs = 945       

Lines = 1801 

Words =  6204 

 Characters = 66311

 Graphics = 15

 Size = 261 KB


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Facility VP (Issue-3)
$89.00
10000510
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/facility/utility equipment using electronic controls or monitoring.

Document Statistics

 Protocols = 1

Pages = 33 

Paragraphs = 688        

Lines = 1332 

Words =  6794 

 Characters = 36210

 Graphics = 12

 Size = 317 KB


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Facility VRA (Issue-3)
$125.00
10000515
The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the facility 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 =  3151 

 Characters = 20084

 Graphics = 10

 Size = 179 KB


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Facility DQ (Issue-3)
$115.00
10000520
The Standard Operating Procedure attached to this generic facility 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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Facility IQ (Issue-3)
$115.00
10000525
The Facility Installation Qualification (IQ) is an important step in the overall validation and qualification process for software and networked systems. Our protocol leads you through the detailed requirements. GAMP 4, is used as a general guide, however there are some areas where it is better to stick with the FDA interpretations. Validation Online has extensive validation experience, where we know that there is a regulatory sensitive area we make absolutely certain that our documentation is clear, concise and supplies the information the regulators are anticipating. These protocols have evolved over 15 years use in the pharmaceutical and allied industries.

Document Statistics

 Protocols = 1

Pages = 70 

Paragraphs = 1030     

Lines = 3240 

Words =  7668 

 Characters = 38541

 Graphics = 39

 Size = 740KB


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Facility OQ (Issue-3)
$115.00
10000530
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 Facility 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 = 49 

Paragraphs = 664      

Lines = 5698 

Words =  4571 

 Characters = 28586

 Graphics = 23

 Size = 517 KB


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Facility PQ (Issue-3)
$89.00
10000535
TheFacility 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.

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Package Facility Validation. (Issue 2)
$675.00
10001070
This facility validation package contains: VMP, VP, URS, VRA, DQ, IQ, OQ and PQ. VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.

Document Statistics

 Protocols = 8

Pages = 225 

Paragraphs = 41.96k    

Lines = 11.3k 

Words = 29.59k 

 Characters = 192.8k

 Graphics = 130

 Size = 2291KB


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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.


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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.


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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.


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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.

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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.


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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.


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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.


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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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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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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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Room Air Flow Regime (Issue 3.)
$26.00
11000186
The inter-room and room air flow is design to safeguard the product and often the staff. It is required in this test script to verify that the inter room and or room air flow are as specified in the design specification (drawing). This test script is not in the standard operational qualification, but is available here for direct download.


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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.


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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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Software Quality Verification (Issue 3.)
$16.00
11000190
Test script used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Not Included in standard OQ, 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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Airborne Particle Verification.
$26.00
11000198
It is required in this test script to demonstrate that the air rate of change in the room / area /zone conforms with the user requirement specification. 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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Zone/Room Air Change Rates (Issue 3.)
$16.00
11000200
It is required in this test script to demonstrate that the air rate of change in the room / area /zone conforms with the user requirement specification. 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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