ü DP: difference b/w two applied pressure of two different area.
ü
Relative
humidity(RH): Humidity
concentration of water vapour present in the air. Ratio b/w the actual
water vapour present in the air and the maximum amount of water vapour that air
can hold at a given time which posses the
saturation.
ü BI. USP defines a biological indicator as a characterized preparation of a specific microorganism preparation that provides a defined & stable resistance to a specific str. process.
ü Difference b/w dynamic pass box and static pass box : static pass box use to transfer materials b/w two clean controlled area. dynamic pass box use to transfer materials b/w one uncontrolled area to controlled Env. area .
ü
why
EM is important ? EM is
important to monitor the microbiological growth in the aseptic area coz EM is
the main root cause of contamination of air born particles.
ü
TOC:
is an indirect measure of organic molecules present in the pharmaceutical
waters measured as carbon which combine wd other molecule can produce harmful product. USP 500ppb.
ü CFU: colony forming unit, is a unit commonly used to estimate the concentration of microorganisms in the test sample. visible colonies present in the agar plate × dilution factor.
ü Media: A microbiological culture medium is a substance that encourages the growth , support, and survival of microorganism contains nutrients, growth promotion factors, energy sources, buffer salts, minerals, metals, and gelling agents.
ü Conductivity : is a measure of the ability of water to pass an electrical current coz dissolve salts and other inorganic chemical conduct electrical current , conductivity increases as salinity increases. Siemens per meter or mmho/cm.
ü
MMWC:
Millimeters per water column the pressure exerted by a column of water
of 1 mm in height at 4 ̊C at the std.
acceleration of gravity.
ü Bio burden: as the number of bacteria living on a surface that has not sterilized.
STERILIZATION
ü Sterility: the state free from microorganism. sterilization- a
process by which sterility is done.
ü D-value:
is the time(for heat or chemical exposure) or
the dose(radiation) required for the microbial population to decline by
one log/ decimal point .
ü Z-value:
the no of degrees (C/F) required for decline for one log reduction of
D-value. Z=(T2 -T1)/(logD2-logD1)
ü F-value:
the equivalent time at temp. delivered
to a container or unit of product for the purpose of sterilization calculated
by using a specific value of Z.
ü 
F0 =Str. process equivalent
time: is the in minute for specified temp. that gives the same thermal
lethality as at 121.3 ̊C in one minute. F0 = t€
10 (T-121.3)/Z .
ü RTD:
Resistance temp. detector used to measure temp. by correcting the resistance of
RTD element and temp.
ü Equilibration
time: the period which elapses b/w the attainment of the sterilization temp. in
the chamber and the attainment of the sterilization temp. in all parts of the
load.
ü Hold time:
the period during which the temp. in all parts of the chamber load and any
coolant fluid is held within the sterilization temp. band.
ü SAL(sterilization
Assurance level): A term related to the probability of finding a non-sterile
unit following a sterilization step. It is usually is expressed in the negative
power of 10 i.e. 10-6.
ü Pulse: A
sub cycle at the state of cycle in which vacuum & steam are alternatively supplied to a steam
sterilizer chamber , for the purpose of removal of air from the chamber.
ü Overkill
sterilization: A cycle which provides a minimum 12 log reduction of resistant
biological indicator with a known D-value of not less than 1 minute. This
approach assures substantially greater than 12log reduction of bio burden and
therefore only minimum on bio burden is required.
ü Type of
Sterilization : a) Thermal and b) Non-thermal.
ü a)
Thermal: by applying heat.
· Dry heat: by oxidizing the
protein. 2 hrs at 140 ̊C or 45 min at 260 ̊C. HOT AIR OVEN: two types 1. natural convection and 2.forsed
convection(provide blower circulate the heated air around the object at the
chamber.).DRY HEAT TUNNELS: moving
belt through a tunnel .2hr. at 180 ̊C. used for power and glass vials .
· Moist Heat :By Protein coagulation .The thermal
capacity of steam is much greater than
that of hot air. 100 ̊C gives 540 cal.
524cal in 121.3 ̊C.
|
Temp.
̊C |
Holding
time |
kPa. |
Psi. |
Inactivation
factor. |
|
115 |
30 |
69 |
10 |
5 |
|
121 |
15 |
103 |
15 |
10 |
|
126 |
10 |
138 |
20 |
21 |
|
134 |
3 |
207 |
30 |
40 |
· combination Treatment: Tyndallisation: 100 ̊C and Inspissations at 60 ̊C .old method of sterilization.
·
NON-THERMAL:
1. Radiation Sterilization : UV mercury vapour lamp, excitation lower state to higher state inhibits the cell metabolism. 253 7 A ̊
(253.7nm) which kills in 1100s B. subtilis
spore.
· Ionizing str. are high energy radiations emitted from radioactive isotopes as cobalt-60(gamma rays) or produced by mechanical acceleration of electrons to very high velocities and energies(cathode rays and beta rays). 2 to 2.5 megarads.
· Electron accelerators: 2types ,linear(3 to 15 MeV) and van de graaff(3 MeV).
· 2.Filtration Sterilization: filters are composed of plastic polymers, including cellulose acetate and nitrate , nylon, polyvinyl chloride, polycarbonate, poly-sulfone and Teflon. MOA. by sieving or by screening particles from solution or gas. pore size 0.2µm .
·
3. Chemical Process: Gas
sterilization(formaldehyde, sulfur dioxide). Alkylating agent- ethylene oxide, β-propiolactone,
propylene oxide. EtO. Humidity 90% and 60mins. 55 ̊C .used
for powder (dry syrup). β-propiolactone> 2 to 4 mg per ltr. of space temp.
nmt. 24 ̊C humidity 70%. Oxidizing gas(ozone, H2O2)
· Surface Disinfectant: Envishield- 5%,20% Ultrabasil :-2%, 2% , ID-401:- 0.4%, 0.8%
· New technologies: Ultra high pressure, High intensity light pulse, gas plasma.
· Biological Indicator used for the evaluation of Sterilization Process.
§
Moist Heat:
Bacillus stearothermophilus
Bacillus subtilis clostridium sporogenes
§
Dry Heat: Bacillus
subtilis var niger .
§
Ionizing radiation: Bacillus pumilus.
§
Filtration: Pseudomonas
diminuta or Brevundimonas diminuta.
§
Ethylene oxide: Bacillus subtilis var
niger .
§
H2O2 and peracetic acid : stearothermophilus , clostridium
sporogenes , Bacillus subtilis
§
Formaldehyde:
Bacillus subtilis var niger
