Standards and safety/environmental regulations shape the way product is manufactured. Here’s a “heads-up” about new and ongoing activities:
Cleaning of Surfaces (ISO Working Group)
Medical Device Cleaning and Validation (ASTM)
ASTM Bearing Cleaning (ASTM)
VOC exemption (U.S. EPA)
Degreaser Rule (Delaware)
Why we get involved
Understanding standards, guidance documents, and regulations helps us to be more efficient, effective critical cleaning consultants – we do a better job of helping you, the manufacturer. Standards and regulations are put together through the best efforts of the people involved. Consensus standards don’t mean that everyone totally agrees with the outcome, simply that we have achieved – consensus. By becoming involved in standards developing, by tracking the reasons for governmental regulatory changes, we are able to understand your production “microclimate.”
Cleaning Surfaces – New ISO Effort
I am honored to have been appointed as a United States Expert to ISO/TC 209 WG 12: “Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications.” The group had its first meeting in Sparks, NV in earlier this month. This is my first experience in developing ISO standards, so I am particularly appreciative of the guidance, perspective, and kindness of the members of the working group. Given the range of manufacturing activities requiring well-defined, controlled environments, the efforts of the working group are important and quite ambitious. The activities of Working Group 12 have to be considered in the context of two recently published documents; both are part of ISO 14644 “Cleanrooms and associated controlled environments” and both focus on cleanroom work surfaces and tooling. One is “Classification of Surface Particle Cleanliness” [ISO 14644-9(2012)]; the other is “Classification of surface cleanliness by chemical concentration.” [ISO 14644-10(2013)].
Medical Devices – ASTM
ASTM is putting together a “Guide for Validating Cleaning Processes for Medical Devices.” (Work Item Number 33660). This is a new guide; it is still under development by the F04.15.17 subcommittee. It is concerned with validating cleaning processes for medical devices during initial fabrication and assembly; so it does not deal with re-cleaning after initial use. Both Ed and I have participated in a number of meetings; and discussions have been lively and productive. The product promises to be a positive addition to the medical device community.
Bearings – ASTM
I will head-up a new effort to update “A Guide for An ODS-Free Cleaning Process for Bearings and Bearing Components” (ASTM F34.03 Subcommittee). Why am I doing this? I’m still asking myself this question. Actually, there are some pretty good reasons. Here are some points taken from my ASTM proposal.
Bearings are used in a range of applications that include many high-value products. Examples of products that incorporate bearings include mission-critical hardware for military applications, medical devices, and seismic protection. Long-term reliability is essential for national, public, and patient safety.
Since 2005, the most recent draft of the update, there have been changes in the complexity and in some cases the quality of the supply chain. Regulatory pressures have increased. Many chemicals and processes thought to be essential to bearing manufacture are subject to increased regulation, including production phaseout and usage bans by agencies tasked with assuring worker safety and environmental safety. Such regulation is not restricted to ODS (Ozone Depleting Substances). Therefore, a new guide is needed to factor in current constraints including VOC (volatile organic compound) restrictions and worker exposure concerns.
EPA VOC Exemption
As we’ve indicated (CleanSource, Sept. 2012), HCFC 225 is scheduled for a production and usage phaseout as of January 1, 2015. Because HCFC 225 is remarkably reminiscent of the legendary CFC 113(Freon 113), we need substitutes. Therefore, it is of interest that the EPA recently listed 1-chloro-3,3,3-trifluoropropene (Solstice™ 1233zd(E) or Solstice™ Performance Fluid, manufactured and sold by Honeywell) as being exempt from the definition of VOC. This covers the Federal level; of course States and locales may choose a different approach. We hope California will follow the Federal exemption in an expeditious manner. We’ll keep you posted. The new material has different properties than CFC 113 or HCFC 225. For one thing, it has a much lower boiling point; so equipment changes are likely to be needed. Hopefully, azeotropic blends will become available.
Delaware – new degreaser rule planned
In 2012, the Ozone Transport Commission passed a Model Rule that covers vapor degreasing and cold cleaning (cleaning below the boiling point). Delaware is proposing to adopt a rule based on the OTC model rule. The current regulation in Delaware is Section 33.0 “Solvent Cleaning & Drying” of Title 7 DE Admin Code 1124 “ Control of Volatile Organic Compound Emissions”. The OTC model rule is itself based on Southern California regulations. We provided comments to the OTC during rule development (CleanSource October, 2011). Unlike the SCAQMD Rule 1122 in California, the OTC model rule provides for solvent cleaning in open-top degreasers However, with the exception of electronics assembly cleaning, where up to 150 g/L VOC is allowed, the model rule calls for a maximum of 25 g/L VOC for most other applications. The presumption appears to be that electronics assembly is the one high-value application that requires the additional solvency and wetting properties provided by the somewhat higher VOC cleaners. The Delaware rule is expected to be finalized by mid-2014.
OTC Rule
