Whether you just want to check your equipment’s efficiency, or you require an independent validation for other 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
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 assist in validation of those materials to the required standards in conjunction with 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, applying 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 over 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 and Filter Integrity personnel have been active members of the committee for many years.

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 of the series have been issued over the subsequent years, with the latest update issued in 2019 to Part 4 – Contaminant Measurement. Particle Content.

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.

For assistance with compliance please contact us.

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.

For assistance with testing protocols please contact us.

Filter Integrity Ltd

Systems Review

Being active on the UK Technical Committee for development of air filtration standards and protocols, our consultants can offer insight into testing standards and the application of instrumentation and rig design in compliance with both the letter and the spirit of the applicable standards for a range of air filtration products.

We can offer insight into your projects associated with environmental impact, medical application, high quality research requirement, general industrial systems, HVAC, PPE, IAQ and virtually all areas where air purification or the removal or generation of aerosol particles is a consideration.

Let Filter Integrity assist in the review of your proposed testing activity.

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 often 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 UK Laboratories to bring accredited testing and validation to users and developers of compressed air filtration equipment.

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 can assist you.

Filter Integrity Ltd


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.

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