By Shikha Agrawal, Megha Agrawal, Shyamasri Biswas, Kim Van Vliet, Contributing Editors

Vacuum Sanitization
and Sterilization Offer Hope
for Pharmaceutical, Food and
Medical Industry

acuum technology plays key

roles in the sanitization and sterilization steps for many biotech
applications in medical, pharmaceutical
and food sectors. Sanitization and sterilization are very important processes for
maintaining the quality of many products.
Pharmaceutical companies and medical
industry face serious contamination-control challenges that can be overcome by
having an adequate sanitization and sterilization methodology in place. Product
quality and employee health are threatened by potent compounds like microbes
and debris during every step of drug production from milling to packaging. Vacuum technology offer hope to overcome
such challenges. Further, the ability of
the bacteria, fungi, and other microbes
was not recognized when they were rst
discovered. They were not an immediate
concern for scientists and it was only after
a couple of decades that researchers realize that germs cause disease. Research
undertaken in this direction demonstrated
the importance of developing sterilization and sanitization systems that could
kill these microbes. In recent years, there
have been developments of vacuum based
sterilization and sanitization methods for

36

the contamination control that are being

implemented by the medical and pharmaceutical industry for better quality of the
end products.

Today, biotech, pharmaceutical and

chemical facilities where sterile products
are manufactured operate a series of vacuum technology enabled rooms called

Figure 1. Vacuum operation for the ultimate cleaning equipment for cleanrooms. Such a facility
is perfect for use in cleanrooms, research labs and other critical environment. Four-stage ltration system includes two paper bags, main lter, microlter and ULPA exhaust lter. [Source:
Nilsk industrial vacuum solutions, 2011]

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April 2016sVacuum Technology & Coating

cleanrooms to control these threats and

other lurks. Cleanrooms are rated by the
cleanliness of the air by the measurement
of particles and are designed to minimize
and control contamination. However,
there are some challenges to maintain the
efficiency of a cleanroom. For example,
atmosphere contains dust and microorganisms, and they represent as sources of
contamination. All the efforts and expense
involved in creating the contaminant-free
atmosphere inside the cleanrooms may
get wasted if not maintained properly that
is free from such atmospheric contaminants. Maintaining environmental control
and cleanroom standards in a pharmaceutical manufacturing facility primarily depends on their cleaning and disinfection
methods. The selection of appropriate
disinfectants, their proper application and
validation to inactivate the contaminants
is the basis of the successful operation of
a cleanroom.
Cleanroom Vacuum Applications
The first cleanroom-packaged vacuums
were originally developed with HEPA,
which is now replaced with ULPA, filtration. For better and improved decontamination, sanitization, and validation they
are built corrosion-resistant, stainless steel
construction and are approved for cleanrooms up to ISO 4 (Class 10) [1].
Biotech cleanrooms use vacuum cleaners containing a multi-stage, graduated
filtration system with HEPA filters for
maximum efficiency to ensure that tiniest
of the particles including 0.3 microns are
collected and retained. It is important that

the HEPA filter be installed after the motor to filter the exhaust stream as the motor commutator generates dust which will
otherwise released into the environment.
Some cleanroom vacuums are designed for stationary suction during manufacturing and fabrication processes in
pharmaceutical facilities, and collect dust
and hazardous material directly from the
source (Figure 2) [2].
Explosion-proof Vacuums for Collecting Combustible Dust
There are facilities that are at major
risk of combustible dust explosion across
the industries. This industrial explosion
hazard can be controlled, and the people
along with the facility can be protected by
eliminating the combustible dust with the
use of certified explosion-proof vacuums
as part of the regular plant maintenance
program. Some explosion-proof vacuums
can be directly attached to the grinding
and sanding tools to capture combustible dust before it becomes airborne. Situations when electricity is unavailable or
undesirable, safe pneumatic vacuums are
excellent alternatives to electric explosion-proof vacuums.
Vacuum Steam Sterilizer
The proper sterilization of medical devices, surgical instruments and equipment
utilized in direct patient care and surgery
directly impacts patients safety and is a
critical aspect of the modern health care
delivery system. Surgical instruments and
reusable medical devices that enter sterile tissue or the vascular system require

Figure 2. Cleanroom vacuums for stationary suction: Models of pharmaceutical industry vacuums for total dust control. [Source: Pharmaceutical Vacuums and Cleanroom Vacuums].

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proper sterilization before each use. Incomplete sterilization or contaminated

medical devices used in patient care can
contribute to surgical site infection and
can pose a risk to patients safety and welfare resulting in a serious life threatening
condition or even death.
Sterilization is a complex multi-parameter process and it is imperative that
healthcare staff and technicians have a
thorough knowledge and understanding
of the scientific principles and protocols
of sterilization involved in the reprocessing and sterilization of medical devices
and surgical instruments.
Vacuum steam sterilizer is adapted for
the decontamination and sterilization of
surgical devices, open containers, instruments, and porous or non-closed products
in medical and pharmaceutical industry.
The sterilization is achieved with a builtin vacuum pump used for fractionated
pre-vacuum air removal eliminating air
pockets from all load types and maximizing efficient steam penetration throughout
the entire load. After the sterilization stage
the vacuum pump is used for post-vacuum drying (Figure 3 (A)).
Laboratory Steam Sterilizer
Saturated steam under pressure is economical and most widely used effective
and reliable method of sterilization available to health care industry. The sterilizer is consists of a pressurized chamber
to elevate and hold the temperature and
are designed to eliminate all air from the
chamber during the conditioning phase
in the sterilization cycle to ensure direct
contact of the steam to all the surfaces to
be sterilized. Steam serves as the channel
to rapidly pass through packaging delivering high temperature moist heat to all
the contents and destroying the microorganisms by coagulating and denaturing
their cell proteins. Only heat and moisture
stable medical devices and instruments
may be sterilized this way due to the high
temperature and moisture associated with
steam sterilization.
In research and analytical laboratories
high performance steam sterilizers are
used [3]. These sterilizers are primarily
designed for the sterilization of laboratory media, water, pharmaceutical products,
glassware, regulated medical waste and
37

Figure 3. (A) Vacuum Steam Sterilizer and (B) Laboratory Sterilizer [Source: Lancer getinge group, Life Science, 2016].

non-porous articles which are in direct

contact with steam during sterilization.
The high performance steam sterilizer
employs gravity downward displacement
with positive pulse conditioning as well
as pressure and vacuum pulsing to manage solid and liquid loads. All preprogrammed cycle phases are automatically
monitored and documented by the control
system (Figure 3 (B)).
Limiting food allergies and cross contamination
Allergens, harmful bacteria, insects
and rodents cause food contamination
which cost hundreds of millions of dollars to food manufacturers and resulting
food allergies cause frequent emergency
room visits. Yet, in a recent survey, only
less than 50% of ice cream, and bakedgoods manufacturers were employing
procedures to control cross-contamination of foods with allergens [4]. The Department of Agriculture recommends that
food companies adopt Sanitation Standard Operating Procedures (SSOPs) and
proper cleaning practices with careful
vacuuming. Vacuums stops the spread of
dangerous pathogens otherwise distributed via brooms/mops and compressed air
-limiting cross contamination of food in
production lines. Vacuums not only protect food products from harmful bacteria,
allergens, and insect but also elevate the
manufacturing and packaging plants to

38

the next level in cleanliness so the food

products are safe.
Steam-Vacuum Sanitization or
Vacuum/Steam/Vacuum (VSV)
Surface Intervention
According to the Center for Disease
Control (CDC), millions of people get
food poisoning every year [5]. Unprocessed raw food harbor pathogenic bacteria, such as raw chicken that often has
pathogenic bacteria in and on the surface,
for example Salmonella and Campylobacter. Researchers have developed a
sanitization process called the Vacuum/
Steam/Vacuum (VSV) surface intervention process for destroying bacteria on
the surface of food, especially raw food.
A prototype surface intervention processor was designed, fabricated, and patented
with optimal processing conditions for
destroying bacteria on the surface of raw
chicken. Cycling the treatment significantly improved the microbiological destruction. Steam is capable of destroying
pathogens but can thermally damage the
food surface if exposed for longer time
however, air and water on the surface of
the product act as insulation. VSV surface
intervention employs a short exposure to
vacuum to remove these insulating fluids
followed by a quick burst of condensing
steam that rapidly transfers the energy
directly to the bacteria and a second exposure to vacuum which cools down the

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product surface, preventing thermal damage. The process time is very short and is
of the order of 12 s.
Studies have also shown the steamvacuum sanitization reducing aerobic
plate counts associated with bovine faecal contamination on beef carcass short
plates [6]. Steam vacuuming is said to
be very effective at reducing the number
of E.coli on beef and has gained wide
acceptance as an effective tool for spot
treatment on the slaughter floor. Steam
vacuuming has been approved by the US
Department of Agriculture (USDA) as a
substitute for knife-trimming for removal of fecal contamination.
Steam vacuuming used as a sanitation treatment in meat processing with
contamination especially of fecal origin
containing pathogens can prove useful
in reducing accidental and unnoticed
contamination. The processing and
preparation of meat for consumption
should also be performed properly using good hygiene practices. Appropriate
implementation of sanitization and sterilization techniques, such as steam vacuuming along with adequate processing
strategies, should lead to consistently
cleaner carcasses with minimal contamination. Food products should be healthy
and safe for consumption following adequate cooking [7].
Assuming that the bacterial contamination is predominantly on and in the
surface of the fruits and vegetables we
April 2016 Vacuum Technology & Coating

usually wash them to remove dirt and the

accompanying bacteria. However, washing with water has minimal effect in removing the bacteria from the surface of
produce. The VSV surface intervention
process designed by [5] destroys bacteria on raw fruits and vegetables also. The
VSV process offers the advantages of using only water, is fast (12 s), and causes
little or no thermal damage.
Concluding Remarks
Vacuum based various sterilization and
sanitization methods and their applications with scientific principles as well as
the monitoring and record keeping habits
can help to ensure effective sterilization,
patient safety, and cost-effectiveness.
More research and developments in this
direction are required to invent new vacuum based technologies for further lowering the cost of sterilization and sanitization. This is an area of research where
vacuum technologists can closely collaborate with biotechnologists and pharmacology experts to ensure the highest quality of the medical products.

References for Further Reading

1. Cleanroom Vacuum Cleaner. Nilfisk industrial vacuum solutions, 2011.
2. Pharmaceutical Vacuums and Cleanroom
Vacuums, Improve plant maintenance with
high-quality industrial HEPA vacuums.
3. Lancer getinge group, Life Science, 2016.
4. Letter to Acting Principal Deputy Commissioner of the Food and Drug Administration. Center for Science in the Public
interest (CSPI) Newsroom. April 2, 2001.
5. Michael Kozempel, E. Richard Radewonuk, O.J Scullen, Neil Goldberg. Application of the vacuum/steam/vacuum surface
intervention process to reduce bacteria on
the surface of fruits and vegetables. Innovative Food Science & Emerging Technologies, Volume 3, Issue 1, April 2002,
6372.
6. W.J. Dorsa, C.N. Cutter, G.R. Siragusa. Effectiveness of a steam-vacuum sanitizer foe
reducing Escherichia coli O157:H7 inoculated to beef carcass surface tissue. Letters
in Applied Microbiology, 1996, 23, 61-63.
7. E Ortega-Rivas. Steam Vacuuming. Encyclopedia of Food Microbiology by Carl A.
Batt, Volume 2, 2014, 982-984.

Guest Contributing Editor

Shikha Agrawal received her Masters
degree in Medical Pharmacology from
Teerthankar Mahaveer University, India
in 2012. She carried out her thesis work
in the Department of Pharmacology with
a primary research focus on evaluation
of the utilization of oral hypoglycemic
drugs in diabetic type 2 outpatient clinics
of a teaching hospital in North India, and
her work was published in an international journal IJPRBS, 2013; volume 2(3):
248-259. Shikhas research significantly
benefited a large number of diabetic patients in India that helped them gain a
good knowledge and understanding of
how and when to use oral hypoglycemic
drugs. Her research has demonstrated a
clear impact of sedentary lifestyle on type
2 diabetic patients. Shikha worked in the
Haemo-Dialysis Department at Da-Vita
(leading provider of dialysis and kidney
care services). She is currently a Lecturer
in Medical Pharmacology in Delhi, India,
where she teaches medical professionals
who are preparing for their Doctor of
Medicine (MD) examinations. She has
also given invited lectures in pharmacology at a number of medical institutions in
Russia. Shikha Agrawal can be reached
at shakes1987@gmail.com.

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