B.Pharmacy (Semester VII) Examination, 2017
STERILE DOSAGE FORMS
Day and Date Thursday, 4-5-2017 Total Marks 80
Time 3.00 p.m. to 6.00 p.m.
Instructions • All questions are compulsory.
• Figures to right indicate full marks.
1. Choose the appropriate option. (16×1=16)
Cryoscopic method of calculation of isotonic concentration is based
on
Freezing point depression Molar concentration
Sodium chloride equivalent method None of the above
USP prescribes test for parenteral plastic containers.
In-vivo biological reactivity test In-vitro biological reactivity test
Both a and b None of the above
Self-sealability test is applicable to type of container or
closure.
Glass containers Plastic containers
Rubber closures All
As per cGMP, permitted limit for solid content in Water for injection is
0.1 ppm 10 ppm
100 ppm 1000 ppm
Co-solvent used in the preparation of parenteral product is
Benzyl alcohol Methyl alcohol
Dimethyl acetamide Phenol
D-value in sterilization is defined as
Time in which 90% of total microorganisms are killed
One log cycle decrease in Z-value
One log cycle decrease in F-value
None of the above
Globule size used in parenteral emulsions is
0.1-0.5 0.5-5
5-10 None of the above
Injection by IV route can be given as
Bolus Drip
Both a and b None of the above
Type-I glass contain of boric acid.
13 80
5 70
10) is the tonicity adjuster used in sterile preparations.
Sodium chloride Boric acid
Dextrose All of the above
11) RGP contact lenses means
Rapid gas partition Rigid glass partition
Rigid gas permeable Rivers gas permeable
12) To avoid leaching, rubber closures can be laminated with
PVC Silicon Oil
Teflon All the above
13) The instruction "NOT FOR USE IN NEWBORNS" is applicable for label
of
Sterile water for injection Water for injection
Bacteriostatic water for injection All of the above
14) Which of the following strength of Dextrose injection is isotonic
2.5 w/v 09 w/v
w/v 1.9 w/v
15) Laminar air flow is used for
Aseptic techniques Incubation
Fermentation All of the above
16) In TPN of dextrose is used.
30-40%
60-70%
2. Answer any four.
Write a note on artificial tears.
How is the validation of HEPA filter done
Define sterilization. Explain dry heat and moist heat sterilization.
Write a note on master document record.
Write a note on occusert.
3. Answer any four.
Give a neatly labeled plant layout of parenteral unit.
Write the procedure involved in Bacterial Endotoxin Test and give its
advantages.
Explain types of contact lenses.
Write general considerations for ophthalmic preparations.
Highlight the need for total Parenteral Nutrition. Give its composition.
4. Answer any two.
Explain in detail quality control tests for parenterals.
Explain in detail scale up techniques used for pharma products.
What is Blow Fill Seal technique Explain in detail.
5. Answer any two.
What are the advantages of glass over other materials of containers Explain
any two Q.C. tests for glass.
Explain the types gowning material used in sterile manufacturing area. Explain
clean room entry and exit procedure.
Define ophthalmic solutions. Explain the Q.C. tests for ophthalmic preparations.