Medical Design Briefs - September 2023 - 18

Crucial Role of Cleaning
difficulty of thorough cleaning
and can trap contaminants.
The cleaning process must
be carefully designed to ensure
that it meets the cleanliness
standards required for medical
devices. It is important to
select a cleaning process that
effectively removes contaminants
without causing damage
to the delicate components or
surfaces that are often used
within medical devices. Additionally,
the chosen cleaning
method must be compatible
with established procedures
and offer consistency and ease
of use to meet process validation
requirements.
Vapor degreasers can accommodate small batch work or massproduced
parts.
perature, time, and equipment, are
properly controlled and optimized to
consistently achieve the required level
of cleanliness for the device throughout
the manufacturing process.
4. Quality Assurance: Cleaning helps
manufacturers establish protocols that
maintain the devices' performance
and prevent any adverse effects resulting
from residues or contaminants.
5. Documentation and Traceability:
Process validation requires comprehensive
documentation of the cleaning
process, including standard operating
procedures (SOPs), cleaning
methods, parameters, and validation
results. It enables manufacturers to
track and evaluate the effectiveness of
the cleaning process over time.
Challenges in Cleaning Complex
Medical Devices
Cleaning electronic medical devices
poses specific challenges due to their
intricate designs, tight spaces, and multifaceted
PCB designs that are difficult
to clean and dry. Traditional cleaning
methods may struggle to remove contaminants
from these hard-to-reach areas
effectively. Furthermore, the smaller size
of modern medical devices adds to the
18
The Benefits of Vapor
Degreasing
Vapor degreasing is a well-engineered
cleaning process that
offers several benefits when
cleaning electronic medical
devices. In a vapor degreaser,
the cleaning process occurs
within a closed-loop system
comprising two chambers: the boil sump
and the rinse sump. The boil sump contains
a specially formulated low-boiling,
non-flammable cleaning fluid. Parts are
immersed and cleaned inside the heated
fluid, then transferred to the rinse sump
for a final rinse and dry. This process ensures
that the components emerge clean,
dry, spot-free, and immediately ready for
the next steps in the manufacturing process,
such as assembly, finishing, sterilization,
or final packaging.
One significant advantage of vapor
degreasing is its effectiveness in cleaning
delicate medical device parts without
causing damage. Modern cleaning fluids
used in vapor degreasers are specifically
engineered with low boiling temperatures,
low surface tensions, and low viscosities.
This allows the cleaning fluid to
penetrate tight spaces, dissolve contaminants,
and evaporate without leaving
residue behind. Modern cleaning fluids
also combine higher density and lower
viscosity, which aids in lifting and floating
particulate from the parts, ensuring
thorough cleaning.
In addition to its cleaning effectiveness,
vapor degreasing offers other benefits
that simplify the process validation
for medical devices. The consistency
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of the cleaning process is a key advantage.
Once established and tested, the
cleaning fluid inside the vapor degreaser
remains chemically stable for thousands
of uses, eliminating the need for
frequent maintenance and daily monitoring.
This stability ensures reliable
cleaning results that comply with process
validation specifications.
Because vapor degreasers come in
various sizes, they can accommodate different
batch sizes and part geometries.
Whether small batch work or mass-produced
parts, the cleaning results remain
stable and repeatable. This eliminates
the need for equipment additions or
updates when introducing new products,
even if they are of different sizes
or made from different materials. The
consistency and auditable nature of
the vapor degreasing process simplify
validation requirements, as a complete
cleaning record can be maintained to
demonstrate adherence to defined procedures
and instructions.
Importantly, vapor degreasing offers
reliability and repeatability, making the
documentation simple. The systematic
nature of the process facilitates easy
engineering, auditing, and streamlined
recordkeeping. It allows for comprehensive
tracking of the cleaning history
of a batch, demonstrating adherence to
defined procedures and instructions and
validating the expected outcomes.
If parts are manufactured within a
cleanroom environment, vapor degreasing
helps to maintain the necessary environmental
conditions, including temperature
and humidity. No dust, fumes,
heat, or moisture is produced, therefore
eliminating the need for specialized
blowers, fans, or climate control systems
to maintain air quality, temperature,
and humidity.
Finally, modern cleaning fluids used
in vapor degreasing are hostile to pyrogens
and will minimize the bioburden
risk. Because PCBs come out of the vapor
degreaser clean, dry, spot-free, and
cool enough for immediate coating or
packaging, the possibility of bioburden
contamination is reduced considerably
as any moisture is removed making it a
convenient means to validate a cleanroom-compatible
cleaning process.
Reliability and Validation
Cleaning plays a crucial role in process
validation for manufacturing elecMedical
Design Briefs, September 2023
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Medical Design Briefs - September 2023

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