243 | Page International Standard Serial Number (ISSN): 2319-8141 Full Text Available On www.ijupbs.com International Journal of Universal Pharmacy and Bio Sciences 6(2): March-April 2017 INTERNATIONAL JOURNAL OF UNIVERSAL PHARMACY AND BIO SCIENCES IMPACT FACTOR 2.96*** ICV 6.16*** Pharmaceutical Sciences RESEARCH ARTICLE …………!!! VALIDATION OF BUNG PROCESSOR Shridhar .M*, M.P Gowrav, Gangadharappa .H.V Department of Pharmaceutics (Pharmaceutical Quality Assurance) Jagadguru Sri Shivarathhreeswara University, Sri Shivarathreeshwara Nagara, Mysuru- 570015 Karnataka, India. KEYWORDS: Validation of autoclave, Vacuum leak test, Bowie- dick test, Heat distribution test, Heat penetration test. For Correspondence: Shridhar .M* Address: Department of Pharmaceutics (Pharmaceutical Quality Assurance) Jagadguru Sri Shivarathhreeswara University, Sri Shivarathreeshwara Nagara, Mysuru-570015 Karnataka, India. ABSTRACT In accordance with GMP, each pharmaceutical company should identify what qualification work is required to prove that the critical aspects of their particular operation are controlled. The key elements of a qualification and validation programme of a company should be clearly defined and documented. Qualification is the integral part of GMP and there is no effective QA program without qualification. Now-a-days it is mandatory to incorporate qualification activity for any system in the manufacturing premises for all pharmaceutical industries. The purpose of this study is to initially develop the sterilization process parameter for the porous load articles then implement the sterilization process for the porous articles. The process development included qualification of equipment and the articles. The autoclave cum bung processor which is used for the cleaning and sterilizing rubber stoppers, garments and machine parts. Initially installation qualification was done followed by performing the qualification of the equipment by performing Vacuum leak test, Bowie dick test, heat distribution test and heat penetration test. The equipment passes all tests and hence the equipment is suitable for sterilization purpose as it meets the predetermined specification and quality attributes. Hence the autoclave cum bung processor is considered to be qualified.
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243 | P a g e International Standard Serial Number (ISSN): 2319-8141
Full Text Available On www.ijupbs.com
International Journal of Universal Pharmacy and Bio Sciences 6(2): March-April 2017
INTERNATIONAL JOURNAL OF UNIVERSAL
PHARMACY AND BIO SCIENCES IMPACT FACTOR 2.96***
ICV 6.16***
Pharmaceutical Sciences RESEARCH ARTICLE …………!!!
VALIDATION OF BUNG PROCESSOR
Shridhar .M*, M.P Gowrav, Gangadharappa .H.V
Department of Pharmaceutics (Pharmaceutical Quality Assurance)
Jagadguru Sri Shivarathhreeswara University, Sri Shivarathreeshwara Nagara, Mysuru-
570015 Karnataka, India.
KEYWORDS:
Validation of autoclave,
Vacuum leak test, Bowie-
dick test, Heat
distribution test, Heat
penetration test.
For Correspondence:
Shridhar .M*
Address:
Department of
Pharmaceutics
(Pharmaceutical Quality
Assurance)
Jagadguru Sri
Shivarathhreeswara
University, Sri
Shivarathreeshwara
Nagara, Mysuru-570015
Karnataka, India.
ABSTRACT
In accordance with GMP, each pharmaceutical company should identify
what qualification work is required to prove that the critical aspects of
their particular operation are controlled. The key elements of a
qualification and validation programme of a company should be clearly
defined and documented. Qualification is the integral part of GMP and
there is no effective QA program without qualification. Now-a-days it is
mandatory to incorporate qualification activity for any system in the
manufacturing premises for all pharmaceutical industries. The purpose of
this study is to initially develop the sterilization process parameter for the
porous load articles then implement the sterilization process for the
porous articles. The process development included qualification of
equipment and the articles. The autoclave cum bung processor which is
used for the cleaning and sterilizing rubber stoppers, garments and
machine parts. Initially installation qualification was done followed by
performing the qualification of the equipment by performing Vacuum
leak test, Bowie dick test, heat distribution test and heat penetration test.
The equipment passes all tests and hence the equipment is suitable for
sterilization purpose as it meets the predetermined specification and
quality attributes. Hence the autoclave cum bung processor is considered
to be qualified.
244 | P a g e International Standard Serial Number (ISSN): 2319-8141
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INTRODUCTION:
An autoclave is a pressure chamber used to carry out industrial processes requiring elevated
temperature and pressure different to ambient air pressure. Autoclaves are used in medical
application to perform sterilization, and in the chemical industry to cure coatings, vulcanize rubber
and for hydrothermal synthesis1.
Autoclave was invented by Charles Chamber land in 18792. The name comes from Greek auto-
self, and Latin clavis - key, a self- locking device3.
The standard temperature and pressure of an autoclave Processes conducted at high temperatures
for short time periods are preferred over lower temperatures for longer times. Some standard
temperatures/pressures employed are 115 °C/10 psi, 121 °C/ 15 psi, and 132 °C/27psi. (psi=pounds
per square inch). In universal autoclave, autoclaving generally involves heating in saturated steam
under a pressure of approximately 15 psi, to achieve a chamber temperature of a least 121 °C (250
°F) but in other applications in industry, for example, other combinations of time and temperature
are sometimes used. Please note that after loading and starting the autoclave, the processing time is
measured after the autoclave reaches normal operating conditions of 121 °C (250 °F) and 15 psi
pressure, not simply from the time you push the "on" button4,5
.
There are four basic types of autoclaves. These types depend upon the method employed to remove
air from the sterilization chamber: Downward displacement autoclaves, Positive pressure
displacement autoclaves, Negative pressure displacement autoclaves and Triple vacuum autoclave.
The downward displacement autoclave is also referred to as a gravity displacement unit. This is
because of the method of air removal in the sterilization chamber. A pool of water in which an
element is immersed, turns to steam when heated. As steam is lighter than air, it forces the air in the
sterilization chamber downward and out through a drain hole. Once the temperature in the
sterilization chamber is sufficient, the drain hole is closed automatically and the sterilization
process begins.
A positive pressure displacement autoclave is an improvement upon the design of a downward
displacement unit. Steam is created in a second, separate chamber and held until the proper amount
to displace all of the air in the sterilization chamber is accumulated. The steam is then released into
the sterilization chamber in a pressurized blast, forcing the air out through the drain hole and
starting the sterilization process.
A negative pressure displacement autoclave is one of the most accurate types available. Once the
sterilization chamber door is closed, a vacuum pump removes the air. Steam is created in a second,
separate chamber. Once the air has been completely removed from the sterilization chamber, the
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steam is then released into the sterilization chamber in a pressurized blast much like that of a
positive pressure displacement unit.
A triple vacuum autoclave is set up in a similar fashion to a negative pressure displacement unit in
that there is a vacuum pump to remove air from the sterilization chamber and steam is created in a
second, separate chamber or unit. The process begins by the vacuum removing the air, then a pulse
of steam. This is repeated three times, hence the name "triple vacuum" autoclave6.
The working process of autoclave
Basically, steam enters the chamber jacket, passes through an operating valve and enters the rear of
the chamber behind a baffle plate. It flows forward and down through the chamber and the load,
exiting at the front bottom. A pressure regulator maintains jacket and chamber pressure at a
minimum of 15 psi, the pressure required for steam to reach 121 °C (250 °F).
Overpressure protection is provided by a safety valve. The conditions inside are thermostatically
controlled so that heat (more steam) is applied until 121 °C is achieved, at which time the timer
starts, and the temperature is maintained for the selected time.
Figure 1: The temperature profile for a saturated steam vented cycle of autoclave
tₒ to tn is the time interval in the computation of the Fₒ value. F1 to Fn areas represent the lethal dose
provided to the material being treated. The shaded area under the curve obtained through
summation of F1 to Fn values represents the total Fₒ value. In the heating phase, saturated steam is
admitted into the chamber, displacing the cold air until the exposure temperature and corresponding
saturated steam pressure are attained. In the exposure phase, the sterilizing temperature is
maintained by saturated steam for the prescribed exposure time. The cooling phase can be achieved
by slow exhaust (for containers filled with liquids) or fast exhaust (for goods required to be dry
after sterilization). This phase is completed when the pressure reaches atmospheric pressure7.
246 | P a g e International Standard Serial Number (ISSN): 2319-8141
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F0 = Σ 10 (T-121)/z ∆t Where
F0 = F0 Value
T = Average Temperature
z = Value which indicates relationship of lethality to temperature
= 10 °C (assumed)
121 °C = Sterilization Temperature
“F0” is defined as the number of equivalent minutes of steam sterilization at 121 °C delivered to a
load (product)
D-value (decimal reduction value): it is time required at temperature T to reduce a specific
microbial population by 90% or by a factor of 10
Z-value: it is the number of degrees of temperature change necessary to change the D-value by a
factor of 108.
Industrial and scientific autoclaves
Although best known as sterilizers, autoclaves can also be used to carry out all sorts of industrial
processes and scientific experiments that work best at high-temperatures and pressures. Unlike
sterilizing autoclaves, which usually circulate steam, industrial and scientific autoclaves may
circulate other gases to encourage particular chemical reactions to take place. Industrial autoclaves
are often used for "curing" materials. For example:
Rubber can be vulcanized (heated, toughened, and hardened with sulfur) in an autoclave.
Nylon (a plastic) can be made by "cooking" a concentrated salt solution in an autoclave to
encourage what's called condensation polymerization.
Some autoclaves combine elements of both sterilization and industrial manufacture. For example,
natural cork (wooden) bottle stoppers have to be boiled and sterilized before they're suitable for use.
Traditionally, that was done in large water tanks; now it's much more likely to be done on a large
scale in computer-controlled, industrial autoclaves9.
Validation
The documented evidence that the process, equipment, facilities or systems, operating within
established parameters, can perform effectively and reproducibly giving results meeting
predetermined specifications.
Validation master plan
Describes the areas of activities within which validation is to take place and provides an overview
of the status of planning. It lists the areas, systems and projects being managed, defines the status of
validation for each and gives a broad indication of when validation is to be completed. It is a