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Contract Steam Quality Testing

Why use a contract service - Keith Shuttleworth & Associates undertake contract steam quality testing throughout the world for a wide range of pharmaceutical, biotech and healthcare companies and in this specialised field our experience is unparalleled. Because we are routinely undertaking these tests, we have absolute confidence in the results we achieve, without concerns about technique or methodology. For many businesses, the testing of steam quality is a new concept and the provision of independently obtained results allows them to proceed to test on their own, with confidence. Our work is routinely subject to audit by both regulatory authorities and internal/external auditors and we are able to provide them with a high level of confidence in the results we generate.

Skilled manpower is a valuable resource and the ability to call upon test professionals where extensive qualification work is being undertaken allows businesses to concentrate their efforts in areas where they have greater expertise.

Trained Personnel - All personnel used to carry out contract steam quality testing are formally trained Test Persons¹ who have received formal and certified training on a UK National Health Service approved residential course. In addition to their formal training they have extensive experience of conducting steam quality tests on all types of systems around the world.

Equipment - All Test Persons are equipped with an SQ1 Portable Steam Quality Test Kit, a battery powered electronic balance, portable data logging equipment and laptop computers.

Protocols/Reports - The work can be undertaken either to your own, or our protocols. Our reports provide a clear pass/fail statement for each test and recommendations where appropriate. The reports contain details of the test procedures used, any deviations and copies of calibration certification.

Fault Finding - All of our engineers are qualified to provide advice on steam system design and qualification, in addition to undertaking demonstrations of the use of the SQ1 Portable Steam Quality Test Kit.

Fees - Our fees are dependent on the number of tests and points of use. The rates will be based on a daywork rate for travelling time and work on site, plus travel and subsistence expenses at cost. Our experience in carrying out this type of work allows us to carry out a large number of tests in the minimum of time.

Book our services - To book our services or obtain more information, please complete the enquiry form, specifying "Contract Steam Quality Testing". KSA -Enquiries

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 Steam Quality Test Training

Who needs training? - It is vital that those undertaking the testing of steam quality understand the properties of steam, the risks associated with steam quality testing and the impact of the different variables on the test results.

For other personnel, such as those in Validation, QA and Engineering, they should be aware of the derivation of the tests, the regulatory expectations and what steps to take in the event of adverse results..

Training Experience - The training is offered in two formats, basic "hands on" and a  formal training course. The "hands on" training is usually provided by one of our formally trained and certified Test Persons¹. The formal training course will be provided by Keith Shuttleworth who has trained large numbers of personnel around the world, including the UK's Medicines Control Agency (MCA) and who is recognised as a leading authority on the subject of steam quality. Keith has spoken at many forums and conferences on the subject and has an input into the various regulatory/advisory documents produced. Keith was registered as An Authorised Person (Sterilizers)¹ in 1996. 

Basic Training - We can provide a qualified (and certified) Test Person (Sterilizers) to provide training using the SQ1 Portable Steam Quality Testing Kit. The training provided familiarises the delegates with the test equipment, details the hazards involved with steam quality testing and the provision of hints and tips to allow a consistent approach to testing. The training is provided in English.

Formal Training - We provide a 1 day formal training session comprising of a morning theoretical session using a PowerPoint presentation supplemented with comprehensive notes, dealing with the derivation of steam quality and steam quality test limits, basic steam theory, plant and clean steam generation, the test methods utilised and acceptance criteria.

While course are tailored for each company, typical course contents could be:

• The evolution/development of US/European approaches
• Relevant regulations and guidance documents.
• The European approach to validating porous load/equipment cycles.
• The impact on the porous load/equipment process of steam quality.
• The derivation of steam quality test limits.
• Steps required to satisfy both US and European approaches.
• Steam quality testing methodology and acceptance criteria.
• Porous/equipment cycle validation methodology.

This would be followed by an afternoon "hands on" session conducting tests using your equipment on your installation and with your personnel.

This is followed by a summary session where detailed comments and observations will be provided and followed up in writing. Certificates of Attendance are provided for all delegates. The training course and notes are in English.

Fees - Our fees are dependent on the extent of training required. For the "hands on" training, this is conducted at the same rates and terms and conditions as our Contract Steam Quality Testing. The fees for the formal courses will depend upon the number of delegates.

Book our services - To book our services, please complete the enquiry form, specifying "Steam Quality Test Training". KSA -Enquiries

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 Steam System Audits & Consultancy

Audits - Keith Shuttleworth & Associates undertake comprehensive steam system audits which provide a comprehensive analysis of steam systems.

The scope of the audit can include some or all of the following elements:

• Steam system design
• Steam system construction and certification
• Steam system installation
• review of any changes
• Steam system chemical/TOC and microbiological test results and methods
• Physical steam quality test results and methods
• Steam system qualification URS through DQ, OQ and PQ
• Steam system SOP's
• Steam system maintenance procedures

Consultancy - In addition to audits Keith Shuttleworth & Associates undertake a wide range of consultancy activities associated with steam systems. These can include:

• Fault finding and problem solving
• Advice on steam system design
• Advice on steam system construction, installation and certification
• Advice on steam system chemical/TOC and microbiological testing methods
• Advice on physical steam quality testing methods and results
• Development and advice on steam system qualification protocols
• Development and advice on steam system SOP's
• Development and advice on steam system maintenance procedures

Auditor - The audits/consultancy work will be provided by Keith Shuttleworth who has considerable experience of the design, installation and testing of pharmaceutical steam systems. Keith originally trained as a Marine Engineer and was formally trained in both practical and theoretical aspects of steam engineering, in addition to studying Applied Heat and Applied Thermodynamics. Subsequently Keith has worked as an engineering manager in the healthcare and pharmaceutical industries where he has been responsible for the design, installation and qualification of a number of steam installations. Keith has spoken at many forums and conferences on the subject and has an input into the various regulatory/advisory documents produced.

Book our services - To book our services or obtain more information, please complete the enquiry form, specifying "Steam System Audits & Consultancy". KSA -Enquiries

¹ See HTM 2010 Part 1 for definition.

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