Sterility testing of Pharmaceutical Products

Sterility testing of Pharmaceutical Products

1. STERILITY TESTING OF PRODUCTS
( SOLID, LIQUID,OPHTHALMIC AND OTHER
STERILE PRODUCTS AS PER IP )
ARUN G KRISHNAN
ASST. PROFESSOR
DEPT. OF PHARMACEUTICS
EZHUTHACHAN COLLEGE OF PHARMACEUTICAL SCIENCES
THIRD SEMESTER B.PHARM

2. STERILITY TESTING
•Sterilitytestingisdefinedasatestingwhichconfirmsthat
productsarefreefromthepresenceofviable
microorganisms.
•Suchtestisveryimportantformedicaldevices,
Pharmaceuticalpreparationslikeophthalmicpreparations,
injections,infusions,implants,syringes,bandages,
dressings,needles,surgicalinstrumentsetc.

3. PRINCIPLE BEHIND STERILITY TESTING
•Theteststerilityisbasedupontheprinciplethatif
microorganismsareplacedinamediumwhichprovides
nutritivematerialandwaterandkeptatafavourable
temperature,themicroorganismwillgrowandtheir
presencecanbeindicatedbyturbidityintheoriginally
clearmedium.

4. STERILITY TESTING
PROTOCOL

7. Asking sterility testing????????
•Defenition of sterility
•Importance of sterility testing.
•Number of containers and batch selected for sterility
testing.
•CULTURE MEDIA.
•METHODS OF STERILITY TESTING.
•INTERPRETATION.

8. CULTURE MEDIA
1.Fluid thioglycolate medium (FTM).
2.Alternative thioglycolate medium (ATM).
3.Soyabean casein digest medium.(SCDM).

9. 1. Fluid thioglycolate medium (FTM).
•For anaerobic bacteria.
•Composition
L-Cystine
Sodium chloride
Dextrose monohydrate
Yeast extract
Pancreatic digest of casein
Sodium thioglycollate
Papaic digest of soyabean meal
Dipotassium hydrogen phosphate
Resazurin sodium soluble
Distilled water (to make 1000ml)
PH of the medium after sterilization 7.1±0.2

10. 2.Alternative thioglycolate medium (ATM).
•Used turbid or viscid products.
•Incubated, in such a way that to assure anaerobic
conditions.
•Composition
L-Cystine
Sodium chloride
Dextrose monohydrate
Yeast extract
Pancreatic digest of casein
Sodium thioglycollate
Distilled water (to make 1000ml)
PH of the medium after sterilization 7.1±0.2

11. 3. Soyabean casein digest medium.(SCDM).
•Suitable for the culturing of both fungi and anaerobic bacteria.
•Composition
L-Cystine
Sodium chloride
Dextrose monohydrate
Pancreatic digest of casein
Papaic digest of soyabean meal
Dipotassium hydrogen phosphate
Distilled water (to make 1000ml)
PH of the medium after sterilization 7.1±0.2

12. Medium 1 and 2are adjusted to PH 7.1±0.2, medium 3
is adjusted to PH 7.3±0.2 and sterilised by autoclaving at
121
0
C for 20 mints.
Anaerobic condition are required for growth of some
microbial species

17. METHODS FOR STERILITY TEST
•METHOD A : MEMBRANE FILTERATION
•METHOD B : DIRECT INOCULATION

18. •Suitableforthesubstancelikeoil,anointmentthatcan
beputintoasolution,anon-bacteriostaticsolidnot
readilysolubleinculturemedium,asolublepowderora
liquidthatpossessesinherentbacteriostaticand
fungistaticprperties.
•MethodAissuitableforliquidproductswherethe
volumeinthecontaineris100mlormore.
METHOD A : MEMBRANE FILTERATION

19. APPARATUS

20. MEMBRANE FILTERATION APPARATUS FOR STERILITY TESTING
•Closedreservoirandcontainertocollect
thefilterate,betweenwhichaproperly
supportedmembraneofappropriate
porosityisplaced.
•Porosity;0.45µm
•Diameter;50mm
•Flowrate;55-75ml/min
•Pressure;70mmmercury
•Cellulosenitratemembrane-For
aqueous,oily,andweaklyalcoholic
solutions.
•Celluloseacetatemembarnefilterfor
stronglyalcoholicsolutions.

21. MEMBRANE FILTERATION APPARATUS FOR STERILITY TESTING
•Completeunitshouldbefreefrommicroorganisms
incluedingthemembrane,andoperationshouldbecarried
outaseptically.

22. Dilution fluids : Two types of dilution fluids are
used.
•Fluid A(Peptic digest of animal tissue+Water)
•Fluid B(Lecithin/oil+Poly sorbate)

23. Preparations Quantity in each
conatiner of injectable
preparations
Minimum quantity to be
used for each culture
medium
Liquids Less than 1ml
1-40ml
More than 40ml but not more than
100ml.
Total content of a container, half
the contents of a container but not
less than 1ml
20ml
Antibiotic liquid 1ml
Creams,Ointment The whole content of each
container(NLT 200mg)
Catgut other surgical
sutures
3 sections of strand.
Cotton/gauze 100mg
Other medical devices Whole devices

24. Method of test
•For aqueous solutions
•For Ointments and creams
•For injections other than antibiotics.
•For antibiotic injections.

25. METHOD B :DIRECT INOCULATION
•Samples directly inoculated to a culture media.
•Quantities of sample to be used is accordance with
quantity table.

26. Method of test
•For aqueous solution and suspensions.
•For oily solution.
•For oinment and creams.