Services


Whether you just want to check your equipment’s efficiency, or you require an independent validation for insurance purposes, FIL will provide you with thorough testing, support along the way and in-depth documentation that you can pass on to the relevant personnel that require it. Our years of experience in the field give us the insight and skill to be able to offer these services in an effective and methodical fashion to provide you with high quality data that can be used to improve the efficiency of your facilities’ operation.

Testing Validation
Technical Review
Integrity Testing
Accredited Validation
Resources
Filter Integrity Ltd

Witnessed Testing • On–site Validation of Product Testing

Manufacturers of treatment equipment will usually have a well equipped testing facility and it is frustrating that despite this, customers will often require independent external validation.

The Witnessed Testing service from Filter Integrity offers a cost effective approach to satisfying your customer requests using an experienced and qualified Filter Integrity consultant to audit your testing facility and witness either individual or series of tests carried out at your site against identified international standards.

A pre-audit document to support preparation is issued before the visit, with a formal Filter Integrity Validation Report issued after testing is completed, assessed against the requirements of the standards. This will give your customers assurance of your performance claims with an independent oversight of your product validation.

Filter Integrity Ltd

Materials Certification for Filters used in Food Contact or Pharmaceutical Applications.

Having problems identifying EU / FDA / USP requirements for materials used in your filter products?

Filter Integrity Limited can help you identify applicable regulatory requirements for your products and then validate those materials to the required standards at a certified UK test laboratory.

Filter Integrity Ltd

Additional Validation Service Options

Where a range of different sized products are being developed, validation costs and timescales can become significantly increased if each model is to be tested to the standards. Filter Integrity can assist clients in a technical review of key design parameters across the range, using modern advanced modelling techniques such as Computational Fluid Dynamics (CFD) and together with validated simulation data, define a testing protocol to reduce validation lead-time and cost, offering the potential for rapid and cost effective product release.

Alternatively, where a full external validation service remains a requirement, let Filter Integrity manage your product validation at one of our test house partners.

Filter Integrity Ltd

Compressed Air Quality Related Standards

Compressed air treatment equipment has been subjected to the centralised standards of the International Standards Organisation (ISO) for 20 years. ISO formed the technical committee, TC118, which put together a program to harmonise compressed air quality standards back in the late 1980’s.

The initial series of standards, released under ISO 8573, defined quality levels for compressed air systems initially in terms of three main contaminant parameters and was released in 1991. Reviews and updates have been issued over the subsequent years, with the latest update issued in 2010 to the main quality classification defining document ISO 8573: Part 1.

The ISO 8573 series of standards allows a user to define the quality level required for their process and also to specify a quality level to be attained as a specification to treatment equipment suppliers.

Filter Integrity Ltd

Compressed Air Treatment Equipment Performance

More recently, starting in 2007, a series of standards has been released defining how individual treatment equipment should be tested:

  • The ISO 12500 series, which specifies how equipment suppliers must validate the performance of their treatment equipment in terms of particle, oil and bulk water removal.
  • ISO 7183 which specifies how a compressed air dryer should be tested.

 

This allows users of treatment equipment to compare the performance of competitive equipment tested under the same conditions and receive certification of product performance.

Filter Integrity Ltd

Compressed Air Systems Review • Energy Efficiency Savings

Compressed air can be considered as one of the main energy / power distribution services used in industry, with over 10% of the electrical energy supplied to industry used to compress air. In the USA, for example, it accounts for over $4.5 billion of the total energy spend.
Between 70% to 80% of the total cost of a compressed air system is the electricity required to run it, with the remainder being split between the equipment purchase cost and the maintenance costs for the system.
The efficiency of energy conversion in terms of compressed air energy to electrical power supplied to the compressor can be as low as 4% with the remainder ‘lost’ as heat. It therefore makes financial sense to review your compressed air systems to try to improve this efficiency.
Where installations have been in place for many years and perhaps expanded with the growth of your company, the opportunity for re-assessment can:

  • improve air quality
  • enhance system reliability
  • save money.

It has been estimated that improvements in the efficiency of operation of 20-30% can be made in most current compressed air systems.
A systems review can help you assess the potential savings available and also address any contamination issues that may be impacting on your product quality.

Filter Integrity Ltd

Vacuum Systems Review

The majority of Industrial and Medical Vacuum applications are operated based on the use of oil flooded vacuum pumps. The inlet to the pumps are protected with filtration and the exhaust contains high efficiency separators to prevent carryover of the lubrication oil into the exhaust flow.

Filter Integrity offers assistance to OEM´s in the design and testing of their vacuum pumps, to optimise the performance of the oil separation components.

Filter Integrity offers users of vacuum systems an independent audit of their facility and operation to assess filtration performance.

Filter Integrity Ltd

Filter Integrity Testing and Associated Equipment

The pharmaceutical industry is very aware of integrity testing IT requirements, with Pharmacopoeial defined Good Manufacturing Practice (GMP) leading to a requirement for pre– and post– batch production validation of sterilising grade filter integrity.

Integrity testing is also applied in the Beverage and Medical filtration sectors, but not required by regulation.

To achieve this practically, in-situ testing with automated equipment is the optimum solution, with many integrity test instruments now available to facilitate the process. However, the introduction of the ISPE´s Good Automated Manufacturing Process (GAMP) guidelines (currently at GAMP 5 for Compliant GxP Computerised Systems), together with the 21CFR11 regulatory requirements for Electronic Records and Electronic Signatures brought further requirements in development methodology and performance validation for this equipment.

Filter Integrity consultants have many years of experience in this field, including;

  • Responsibility for the design and validation of several integrity test systems and instruments currently in use across the pharmaceutical industry.
  • Serving on Parenteral Drug Association PDA and UK Parenteral Society committees producing current technical guidance for Sterile Filtration applications.
  • Documenting and performing IQ, OQ methodologies and procedures on-site.

We can support both pressure decay, mass flow and aerosol challenge methods and equipment.

Filter Integrity Ltd

Compressed Air Quality Validation

ISO 8573-1 defines quality classes by the level of contamination present in a compressed air line.

Unfortunately there are very few instruments sensitive enough to allow the verification of the quality to the levels identified in the standard, particularly for oil contamination levels.

The development of test instrumentation to allow cost effective quality verification and in situ treatment equipment performance validation is an active area for Filter Integrity and its partners.

Filter Integrity Ltd

Compressed Air Filter Performance Validation

The ISO 12500 series of international standards defines the methods to be used to verify and report performance of compressed air treatment products.

Filter Integrity is developing a capability to independently validate products and is interested to talk to potential partners.

Filter Integrity Ltd

Independent Filter Product Validation

While manufacturers of filtration products generally have their own testing facilities, specifiers and users of premium quality equipment will generally require an independent validation of product performance. When a customer is choosing between products or suppliers an independent comparison always offers valuable data in making the decision.

Filter Integrity Limited has partnered with IBR Laboratories to bring accredited testing and validation to users and developers of compressed air filtration equipment, with facilities located in the USA and UK.

IBR Laboratories can also handle requested testing that is outside the scope of documented standards with capability in design of filtration and separation testing protocols for both liquids and gases.

Filter Integrity Ltd

The Compressed Air Quality Standards

There are two international standard series that have been developed to allow manufacturers and users of compressed air filtration products to verify and validate both the quality of their compressed air in use and the performance of filtration products specified by users to meet their air quality requirements.

The ISO 8573 series of standards gives both specification and testing methodologies for users to apply when specifying the air quality they require for their applications to compressed air system designers and installers.

The ISO 12500 series of standards define test methods to allow compressed air treatment manufacturers to validate the performance of their products and hence their capability in line with meeting the ISO 8573 air quality specifications, currently in four parts:

  • Part 1: Oil Aerosols – removal rates from 5 to <0.01 mg/m3
  • Part 2: Oil Vapours – adsorptive capacity
  • Part 3: Particulates – removal efficiency in Fine: 10 nm – 5 µm and Coarse: 5µm – 40µm ranges
  • Part 4: Bulk Water – capability to deal with bulk water and wall flow

Whether you require comparative performance testing or an independent and accredited validation of performance for enhanced customer confidence in your products, Filter Integrity and IBR Laboratories can assist you.

Filter Integrity Ltd

Documents

Medical Vacuum Systems – Bacterial Filter Requirements and Sizing

The aim of this document is to explain a little about the use of Bacterial Filters in Medical Vacuum Systems and to expand on the sizing considerations and calculations required to ensure that filters are able to meet the required performance.

Compressed Air Quality Standards ISO 8573 Part 1 – 2010 Revision

This document gives an overview of the standards developed to support qualification testing of compressed air systems and treatment products and highlights the changes implemented in the new ISO 8573-1:2010 standard compared to the 2001 version it replaces.

To review your requirements, please leave a message and we’ll get back to you as soon as we can.

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