WORKING IN ASEPTIC AREA YOU HAVE TO KNOW (part-I)

 

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