Ahmed L. Al-Aoufi Teaching Assistant Pharmaceutical Dept. PHT 351

Sterilization Definition: It is the process of killing or removing bacteria and all other forms of living micro-organisms and their spors from the pharmaceutical products (preparation). Sterile product: It is free from all living microorganism and passes the sterility test.

Other terms used in relation to sterilization: *Antiseptics: These are the substance used to inhibit the growth or destroy germs. They are used on the skin. *Bactericides: These are the substance used to kill the microorganism. *Bacteriostatic Agents: These are the substance which inhibit the growth of bacteria. Different bacteriostatic agent used against different bacteria.

*Disinfectants: These are the substance used to kill bacteria and other infectious agents from the non- living material. they are too strong to be applied to the human body. as: phenol, cresol, eresol with soap solution and chloroxylenol. *Fungicides: These are substance which kill fungi. *Mycocides : These are the substance which kill molds. *Viricides : These are the substance which kill viruses.

Aseptic Processing : These operation performed between the sterilization of an object or preparation and the final sealing. These operation are carried out in the complete absence of microorganisms.

The product or materials which require sterilization 1-All parenteral preparation & its contents. 2-All ophthalmic preparations & its contents 3-surgical instruments 4-surgical dressing & gloves. 5-parentral adminstration sets as syrings [ I.V. sets etc]

Difference between sterilization and disinfection: In sterilization there is complete destruction or removal of all bacteria & their spors, but in disinfection there is destruction of bacteria but not their spors

Methods of Sterilization 1- Dry heat sterilization. 2- Moist heat sterilization. 3- Gas sterilization. 4- Sterilization by ionizing radiation. 5- Sterilization by ionizing radiation.

Comparison Between Different Methods. *process occur: How can sterilization? *lag time *mechanism *advantages *disadvantages *material which can be sterilized *material which can not be sterilized

Sterilization Efficiency Microbial Death Kinetic: D- value : It is the time (for heat) or dose (for radiation) require for the microbial population to reduce by one logarithm unit. Log N u -D= u/Log N o

Ex 1 After 5 min of product exposure to temperature of 121 C˚ the m.o was reduced from 2x10 ⁵ to 6 x10³ calculate D-value at 121 C˚

Solution D = 5/ 5.30 – = min

Ex2: After 10 min of exposure to temperature of 121 C˚ the m.o was reduced from 2x10⁵ to 6x10³ calculate D-value at 121 C˚ and write yuor comment?!!

Solution D = 10/ 5.30 – = 6.67 min Comment: at 121 C˚ the microbial population is decrease 90% every 6.57 min

Ex 3: After 15 min of product exposure to C˚ the population is reduced from 5x 10⁵ to 2x10³ Calculate your D and write your comment?(6.25min)

Resistance value (Z) The number of degree ( C˚) required for 1 log reduction in the D value Z= T 1 - T 2 / log D 2 - log D 1

After certain experiments at C˚ the D was 3.2 min & at C˚ the D was 2.3 min. Calculate Z value?

Z-value: = – / – = 5/0.144 = 34.7

Ex2: After certain experiments at C˚ the D was 6.3 min at C˚ the D was 1.5 min Write your comment

Z = / – = 5/0.623 = 8

Parenteral Preparation Definition: Are sterile preparations intended for administration by injection, infusion or implementation into human or animal body. Special Requirement of P.P. :

Classification of P.P. IV … IM … S.C Site of injection, Onset response, Injection volume, vehicle used, Duration

Disadvant.AdvantagesInjection volume Onset response Site of injection -Need proff. -High SE. -Direct to sys -Avoid 1ts pass metab. -Bioavialab. ↑↑↑Vein IV -Painful e some drugs. - Need local anesthetics -Less SE comparing e IV. ↑↑ -Arm. -Thigh -Buttocks IM - Easy to do. - Can inject at home. -Less painful ↑Subcutaneous tissues SC ( for Insulin)

Quality Control of Parenteral 1- Volume in Container. 2- Sterility testing. 3- Pyrogen testing: Pyrogenic substances are lipid polysaccharide products of the metabolism of m.o. Pyrogen destroy at 175 C ̊̊ for 3 hr, less effective method (2) filtration (3) chemical oxidation or combination of these.

Practical: ml /kg of tested solution (at 37 C) is injected in the ear vein of 3 healthy rabbits ( temp. not exceeding 39.8 C ). 2- Rectal temp. is recorded at 1,2 and 3 hr. Solution is apyrogenic if : - no rabbit shows an individual rise in temp. of 0.6 and - sum of rise in 3 rabbit not exceeding 1.4 C If 2nd limit pass go to doubling so doubling… If temp. rise exceeds these limits, the test is repeated using 5 rabbits, the sample is accepted if: - no individual rise exceed 0.6 C and - sum of rise in the 8 rabbits does not exceed 3.7 C

After 1st exam. Ophthalmic paper. Power point