Innovations at Interphex 2023 - 11

« INTERVIEW
What are their benefits to patients?
Jeff Phillips: Better health outcomes, routes of administration, and
often ease of use.
What are some unique challenges to cleaning
combination devices?
Jeff Phillips: Some of the most difficult cleaning issues are having to
meet medical device and pharmaceutical standards. The code of federal
regulations for pharmaceutical quality management system (QMS)
is 21CFR211 and 21CFR210, while medical device QMS is 21CFR820.
These QMS have some differences and similarities. Navigating these
quality and specifically ways of thinking about cleaning and cleaning
levels requires knowledge of both industries.
Teaming up with a
company like Alconox Inc. goes a long way to avoiding problems and
facilitating optimized critical cleaning.
Environmental and Regulatory Issues
With environmental and green issues making
headlines, what types of aqueous products are
available that minimize environmental issues?
Malcolm McLaughlin: Aqueous products formulated from ingredients
that are on the US EPA safer choice list minimize environmental issues.
These ingredients are safer for human health and the environment and
will typically have better sustainability profiles.
Stacy Silverstein: At the operational level, drain safety is a big
concern. Aqueous cleaners that are mild alkaline or mild acids can be
easily disposed of down the drain without the hazard and headache
of neutralizing. The Alconox Inc. aqueous detergents have the added
benefit of being biodegradable and safer for workers.
Are environmentally safe cleaning agents as effective
as those that aren't safe for the environment?
Malcolm McLaughlin: The history of detergent chemistry has been
one of starting by making products that clean well. Then sometimes
environmental concerns are raised about these formulations.
Improvements in the environmental status are often made at the
expense of cleaning performance. After several potential iterations
and time, a product is designed that has improved performance while
maintaining a good environmental profile. Then the tension between
environmental concerns and performance continues to repeat to
respond to evolving environmental concerns.
Stacy Silverstein: In some cases, " environmentally safe " cleaning
agents are just not as effective cleaners as some more hazardous
cleaners. It's a risk reward scenario. How much risk do you want to put
your staff, equipment and the ground water in to get the most effective
cleaning? There are plenty of safer products in the marketplace that
What points should be considered when evaluating
the environmental health and safety of a proposed
cleaning process?
Malcolm McLaughlin: The safety of the operators using the cleaning
process and the environmental impact of the effluent from the process
is very important to consider.
Stacy Silverstein: Another point to consider in addition to Malcolm's
is the life of the processing equipment itself. Often products that are
more hazardous and harsher on the environment also produce faster
wear and tear of capital equipment.
How do issues such as energy and resources used
factor into the use of aqueous cleaning systems?
Malcolm McLaughlin: Energy and resources used are critical factors to
consider in any evaluation of the sustainability of an aqueous cleaning
system. By optimizing chemical energy in a cleaning process, you can
minimize the need for other forms of energy and resources required.
Are there specific regulations that govern the use
of solvents for aqueous cleaning? What governing
bodies oversee the use of cleaners?
Malcolm McLaughlin: In the United States, the Occupational Safety
and Health Administration (OSHA) governs the use of solvents and
cleaners in the workplace. The US EPA governs the use, reporting and
discharge from cleaning processes. Numerous State and Local waste
regulators or Departments of Environmental Protection govern
permissible discharge in to waste treatment plants.
Toxic Substances Control Act (TSCA) and Resource Conservation and
Reclamation Act (RCRA) regulate the use of solvents, including those
used in cleaners.
Internationally there are comparable organizations
to those found in the US.
balance both safety and effectiveness. Detergent raw material suppliers
continue to introduce new, more environmentally friendly ingredients.
Working with a manufacturer that prioritizes these innovations brings
more reward for prioritizing safety concerns and pristine results.
Are there any special considerations that need to be
addressed when using environmentally-safe products?
Malcolm McLaughlin: Depending on where the product you are using
is on the historical environmental development cycle, it is possible that
it will be a somewhat more poorly performing product. To compensate
for this, you may need to optimize other variables that impact cleaning
performance such as before cleaning handling, amount of mechanical
agitation, cleaning time, and cleaning temperature.
In the US, the
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