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W
ELCO
M
E
.
.
)
Presented by:
B.Kavita
3 rd year
B.pharmacy
GUIDED BY:
Mrs. Ch.Supriya ;
NIRMALA COLLEGA OF PHARMACY
TEST FOR STERILITY FOR PARENTRALS
Asso. professor
Department of Biotechnology
 Aseptic processing : in this components of the final
dosage form are sterilize separately and the finished article
assembled in an aseptic manner.
 Prevents introduction of viable micro-organisms into
components.
 Requirements:
1- Air environment free from viable micro-organisms to permit
effective maintenance of air supply unit.
2- Adequately equipped trained operating personnel.
 The facility include primary and secondary barrier system.
Composition: w/v
Pancreatic Digest of Casein 15.0 g
Yeast Extract (water-soluble) 5.0 g
Glucose monohydrate/anhydrous 5.5 g/5.0 g
Sodium chloride 2.5 g
L- Cystine 0.5 g
Sodium thioglycollate 0.5 g
0.1% Resazurin Sodium Solution (freshly
prepared)
1.0 mL
Granulated Agar (moisture not more than 15%) 0.75 g
Purified Water 1000 mL
Polysorbate 80 5.0 mL
pH after sterilization (measured at room
temperature): 7.1± 0.2 particularly suitable for the
cultivation of anaerobic organisms (incubation temperature
30–35°C)
Medium 1 (Fluid Thioglycollate Medium)

 Mix L-cystine, NaCl, Dextrose, Yeast extract, Pencreatic
digest of casein with purified Water.
Dissolve Sodium thioglyocollate or thioglycollic acid in
solution
if filtration is necessary, heat the solution without boiling and
filter hot through moistened filter paper
Add Resazurin sodium solution,mix,place in suitable vessel and
subject for sterilization process.
(If necessary, add 1N NaOH to adjust pH to 7.1)
 Fluid thioglycollate medium incubated at 32.5oC.
 Shows Pink colour change after incubation.
Medium 2 (Soybean-Casein Digest
Medium)
Composition w/v
Pancreatic Digest of Casein 17.0 g
Pepsin Digest of Soybean Meal 3.0 g
Glucose monohydrate/anhydrous 2.5 g /2.3 g
Sodium chloride 5.0 g
Di potassium hydrogen phosphate 2.5 g
Purified Water 1000 mL
Polysorbate 80- 5.0 mL
pH after sterilization (measured at room temperature):
7.3±0.2
which will support the growth of both aerobic
bacteria (incubation temperature 30–35°C) and fungi
(incubation temperature 20–25°C)
Method of preparation:
Mix solids with purified water
Heat the solution
Cool to room temperature, and add sufficient
quantity of 0.1 N NAOH to adjust the PH of the
medium between 7.1 to 7.5 .transfer to suitable
container and kept for sterilization.
 Store at temperature 20 C – 25 oC.
 Incubated at 22.5oC.
Membrane filtration Appropriate for : (advantage)
Filterable aqueous preparations
Oily ,Alcoholic preparations
Preparations miscible with or soluble in aqueous or
oily (solvents with no antimicrobial effect)
All steps of this procedure are performed aseptically
in a Class 100 Laminar Flow Hood
Membrane filter 0.45μ porosity
Filter the test solution
After filtration remove the filter
Cut the filter in to two halves
First halves (For Bacteria) Second halves (For Fungi)
Transfer in 100 ml culture media
(Fluid Thioglycollate medium)
Incubate at 30-350
C for not less then 7 days
Transfer in 100 ml culture media
(Soyabeans-Casein Digest medium)
Incubate at 20-250
C for not less then 7
days
Observe the growth in the media Observe the growth in the media
Suitable for samples with small volumes
volume of the product is not more than 10% of the
volume of the medium
suitable method for aqueous solutions, oily liquids,
ointments and creams
Direct inoculation of the culture medium suitable
quantity of the preparation to be examined is
transferred directly into the appropriate culture
medium & incubate for not less than 14 days.
Positive controls
small numbers of suitable
microorganisms to grow in media in the
presence of the sample is measured.
The microorganism used for positive
control tests with a product containing an
antimicrobial agent must.
indicates a satisfactory inactivation
To be sensitive to that agent
Culture media is examined during and after at the end of incubation.
The following observations are possible:
1) 1) No evidence of growth Pass the test for sterility.
2) 2)Re-testing is performed with twice no. of sample if:
3) 3) No evidence of growth Pass the test for sterility. There
is evidence of growth Re-testing is performed same no. of
sample, volume & media as in original test No evidence
of growth Pass the test for sterility.
4) 4)There is evidence of growth isolate & identify the organism.
Test for sterility for parentrals
Test for sterility for parentrals

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Test for sterility for parentrals

  • 2. Presented by: B.Kavita 3 rd year B.pharmacy GUIDED BY: Mrs. Ch.Supriya ; NIRMALA COLLEGA OF PHARMACY TEST FOR STERILITY FOR PARENTRALS Asso. professor Department of Biotechnology
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  • 4.  Aseptic processing : in this components of the final dosage form are sterilize separately and the finished article assembled in an aseptic manner.  Prevents introduction of viable micro-organisms into components.  Requirements: 1- Air environment free from viable micro-organisms to permit effective maintenance of air supply unit. 2- Adequately equipped trained operating personnel.  The facility include primary and secondary barrier system.
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  • 7. Composition: w/v Pancreatic Digest of Casein 15.0 g Yeast Extract (water-soluble) 5.0 g Glucose monohydrate/anhydrous 5.5 g/5.0 g Sodium chloride 2.5 g L- Cystine 0.5 g Sodium thioglycollate 0.5 g 0.1% Resazurin Sodium Solution (freshly prepared) 1.0 mL Granulated Agar (moisture not more than 15%) 0.75 g Purified Water 1000 mL Polysorbate 80 5.0 mL pH after sterilization (measured at room temperature): 7.1± 0.2 particularly suitable for the cultivation of anaerobic organisms (incubation temperature 30–35°C) Medium 1 (Fluid Thioglycollate Medium)
  • 8.   Mix L-cystine, NaCl, Dextrose, Yeast extract, Pencreatic digest of casein with purified Water. Dissolve Sodium thioglyocollate or thioglycollic acid in solution if filtration is necessary, heat the solution without boiling and filter hot through moistened filter paper Add Resazurin sodium solution,mix,place in suitable vessel and subject for sterilization process. (If necessary, add 1N NaOH to adjust pH to 7.1)  Fluid thioglycollate medium incubated at 32.5oC.  Shows Pink colour change after incubation.
  • 9. Medium 2 (Soybean-Casein Digest Medium) Composition w/v Pancreatic Digest of Casein 17.0 g Pepsin Digest of Soybean Meal 3.0 g Glucose monohydrate/anhydrous 2.5 g /2.3 g Sodium chloride 5.0 g Di potassium hydrogen phosphate 2.5 g Purified Water 1000 mL Polysorbate 80- 5.0 mL pH after sterilization (measured at room temperature): 7.3±0.2 which will support the growth of both aerobic bacteria (incubation temperature 30–35°C) and fungi (incubation temperature 20–25°C)
  • 10. Method of preparation: Mix solids with purified water Heat the solution Cool to room temperature, and add sufficient quantity of 0.1 N NAOH to adjust the PH of the medium between 7.1 to 7.5 .transfer to suitable container and kept for sterilization.  Store at temperature 20 C – 25 oC.  Incubated at 22.5oC.
  • 11. Membrane filtration Appropriate for : (advantage) Filterable aqueous preparations Oily ,Alcoholic preparations Preparations miscible with or soluble in aqueous or oily (solvents with no antimicrobial effect) All steps of this procedure are performed aseptically in a Class 100 Laminar Flow Hood
  • 12. Membrane filter 0.45μ porosity Filter the test solution After filtration remove the filter Cut the filter in to two halves First halves (For Bacteria) Second halves (For Fungi) Transfer in 100 ml culture media (Fluid Thioglycollate medium) Incubate at 30-350 C for not less then 7 days Transfer in 100 ml culture media (Soyabeans-Casein Digest medium) Incubate at 20-250 C for not less then 7 days Observe the growth in the media Observe the growth in the media
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  • 14. Suitable for samples with small volumes volume of the product is not more than 10% of the volume of the medium suitable method for aqueous solutions, oily liquids, ointments and creams Direct inoculation of the culture medium suitable quantity of the preparation to be examined is transferred directly into the appropriate culture medium & incubate for not less than 14 days.
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  • 16. Positive controls small numbers of suitable microorganisms to grow in media in the presence of the sample is measured. The microorganism used for positive control tests with a product containing an antimicrobial agent must. indicates a satisfactory inactivation To be sensitive to that agent
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  • 23. Culture media is examined during and after at the end of incubation. The following observations are possible: 1) 1) No evidence of growth Pass the test for sterility. 2) 2)Re-testing is performed with twice no. of sample if: 3) 3) No evidence of growth Pass the test for sterility. There is evidence of growth Re-testing is performed same no. of sample, volume & media as in original test No evidence of growth Pass the test for sterility. 4) 4)There is evidence of growth isolate & identify the organism.