IEST-RP-CC034.5-2022 PDF

Full title and description

St IEST‑RP‑CC034.5‑2022 — HEPA and ULPA Filter Leak Tests. This IEST Recommended Practice describes definitions, equipment, and procedures for leak‑testing high‑efficiency particulate air (HEPA) and ultralow‑penetration air (ULPA) filters in the factory, at the job site before installation, and after installation in cleanrooms and unidirectional‑flow clean‑air devices. It also includes procedures to measure the uniformity of the aerosol challenge approaching the filter under test.

Abstract

This document (IEST‑RP‑CC034.5, published 2022) provides recommended scanning and quantitative methods for detecting and characterizing leaks in HEPA and ULPA filters, guidance on equipment and probe geometry, acceptance criteria for spatial uniformity of challenge aerosol, and best practices for in‑factory and in‑situ testing. The revision clarifies procedures and adds content on sample tube length, total leakage testing, spatial uniformity acceptance, and probe head geometry.

General information

• Status: Active / Most current IEST Recommended Practice (supersedes previous editions).
• Publication date: July 2022 (first printing July 2022).
• Publisher: Institute of Environmental Sciences and Technology (IEST).
• ICS / categories: Contamination control; cleanroom technology; aerosol filtration; HEPA/ULPA filter testing.
• Edition / version: IEST‑RP‑CC034.5 (2022 revision).
• Number of pages: 51 pages (IEST bibliographic listing).

Scope

IEST‑RP‑CC034.5 specifies recommended practices for leak testing HEPA and ULPA filters during production (factory), at the job site pre‑installation, and in situ after installation in cleanrooms and unidirectional‑flow, clean‑air devices. The RP is intended to be used alone or in conjunction with other IEST RPs (for example CC001, CC002, CC006, CC007, CC021, CC028, CC036) to form the basis of procurement and acceptance agreements between suppliers and customers. The revision separates recommended procedures for factory and in‑situ testing to reflect differences in variability and test conditions.

Key topics and requirements

• Definitions and terminology for HEPA and ULPA filter leak testing.
• Equipment and instrumentation requirements (aerosol generators, photometers, tubing and probe heads).
• Factory (bench) test procedures and in‑situ (field/cleanroom) test procedures, with separate guidance to account for differences in variability.
• Filter scan methods (scan rates and probe motion) and recommended quantification steps when a leak is detected.
• Procedures for measuring and accepting spatial uniformity of the aerosol challenge approaching filters.
• New and expanded guidance in the 2022 revision: best practices for sample tube length, total leakage test, spatial uniformity acceptance, restriction on circular probe heads (rectangular probe heads recommended), and sample port location considerations.

Typical use and users

Used by filter manufacturers, cleanroom installers, validation engineers, contamination control specialists, HVAC and filtration contractors, and quality/validation teams in industries with controlled environments (pharmaceuticals, biotechnology, semiconductor fabrication, aerospace, medical device manufacturing, and other cleanroom applications). The RP is commonly referenced during procurement, factory acceptance testing, site acceptance testing, and periodic in‑service verification.

Related standards

This RP is intended to be used with other IEST recommended practices covering HEPA/ULPA filters and clean‑air devices, including (but not limited to) IEST‑RP‑CC001, IEST‑RP‑CC002, IEST‑RP‑CC006, IEST‑RP‑CC007, IEST‑RP‑CC021, IEST‑RP‑CC028, and IEST‑RP‑CC036. It also aligns with industry test practices and regulatory validation expectations for cleanroom filtration systems.

Keywords

HEPA, ULPA, filter leak test, aerosol photometer, cleanroom validation, in‑situ testing, factory testing, unidirectional flow, contamination control, filter scan, spatial uniformity.

FAQ

Q: What is this standard?

A: It is an IEST Recommended Practice titled IEST‑RP‑CC034.5 (2022) that provides guidance and procedures for leak testing HEPA and ULPA filters in factory and field environments.

Q: What does it cover?

A: It covers definitions, equipment, aerosol generation and measurement methods, filter scan procedures, criteria for detecting and quantifying leaks, acceptance considerations for spatial uniformity of challenge aerosol, and distinctions between factory and in‑situ testing procedures. The 2022 revision adds guidance on sample tube length, total leakage tests, and probe head geometry.

Q: Who typically uses it?

A: Filter manufacturers, cleanroom and HVAC contractors, validation and quality engineers, contamination control teams, and personnel responsible for acceptance testing and periodic verification of cleanroom filtration systems in pharmaceuticals, semiconductors, aerospace, medical devices and similar industries.

Q: Is it current or superseded?

A: IEST‑RP‑CC034.5 (2022) is the current active edition published in July 2022 and supersedes previous editions of IEST‑RP‑CC034.

Q: Is it part of a series?

A: Yes — it is part of the IEST Contamination Control Recommended Practices series and is intended to be used alongside related RPs such as CC001, CC002, CC006, CC007, CC021, CC028, and CC036 for comprehensive guidance on filters and clean‑air devices.

Q: What are the key keywords?

A: HEPA, ULPA, leak test, aerosol photometer, filter scan, in‑situ testing, factory testing, spatial uniformity, contamination control.