11_Utilities at 009

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Utilities.

Validation Master Plan (Issue 8)
$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

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Size = 789 KB

Quantity

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

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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 you’re DQ’s 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

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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).

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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.

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Quantity

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.

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Quantity

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.

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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.

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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.

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Quantity

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.)

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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

Quality Water IQ (Issue 2)
$115.00
10001096

Document Statistics

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Quantity

Quality Water OQ (Issue 2)
$115.00
10001097

Document Statistics

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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

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Quantity

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

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.

Quantity

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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