Services

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.

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.

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.

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.

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.

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.

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.

• BSI The British Standards Institution
• DIN The German Standards Institution
• ISO International Organisation for Standardization
• FDA – US Food and Drug Association – Code of Federal Regulations 21CFR
• ASME – Boiler and Pressure Vessel Code
• ASTM International – was the American Society for Testing and Materials now renamed
• AS – Australian Standards
• CSA – Canadian Standard B51 Boiler, pressure vessel, and pressure piping code

• BCAS The British Compressed Air Society
• PNEUROP European Committee of Manufacturers of Compressors, Vacuum Pumps, Pneumatic Tools and Air and Condensate Treatment Equipment
• VDMA Germany – Compressors, Compressed Air and Vacuum Technology
• CAGI USA – Compressed Air and Gas Institute
• CAAA Compressed Air Association of Australasia

• IOP The Institute of Physics
• IET The Institution of Engineering and Technology
• VDI The Association of German Engineers
• CIBSE Chartered Institution of Building Services Engineers
• AFS The American Filtration and Separation Society
• EUROVENT – Europe’s Industry Association for Indoor Climate (HVAC), Process Cooling, and Food Cold Chain Technologies
• ASHRAE – American Society of Heating, Refrigerating and Air-Conditioning Engineers