PH3004 MCQs

A sterility assurance level of 10-6 can be defined as

A preservative in a sterile product formulation must

In a moist heat sterilisation process, dry saturated steam must be used because:

Which of the below statements is true about the radionuclide Technetium-99m?

Parenteral preparations are required to be sterile because

With respect to filtration sterilisation, consider the following statements:
1) Sterilisation by filtration involves the killing of micro-organisms through their removal via a filter
2) Filtration sterilisation must be carried out in aseptic facilities
3) The nominal pore size of a sterilising filter is rated according to the retention capability of the filter for specific micro-organisms.

With respect to monitoring and validation of sterilisation processes, which of the following statements is not correct?

With respect to operators working in a clean room, consider the following statements:
1) Operators should work downstream of the air flow in order not to interrupt the airflow from the inlet to the work area
2) Operators should move quickly with minimal movement and conversation in order to reduce the potential for contamination
3) The source of bacteria in a clean room is from personnel; exhaling, speaking, coughing and sneezing can all contribute to bacterial contamination

With respect to hospital pharmacy aseptic services, which of the following statements is incorrect:

With respect to the design of clean room premises, which of the following statements is incorrect?

Which of the following statements is correct?

The Rideal-Walker Test is:

The microdilution broth method involves the use of small volumes of growth medium dispensed in plastic microdilution trays (usually 96-well plate). Specifically, each well should contain total volume of 0.1 ml of broth containing twofold dilutions of antimicrobials and the standardized inoculum of target micro- organism. In addition, each test should without exception include a growth control and a negative (non-inoculated) control.
As the inoculated microdilution trays are usually incubated at 35 ˚C for a certain time before reading the results. The earliest you will be able to provide the result will be:

Parenteral preparations are required to be sterile because

With respect to monitoring and validation of sterilisation processes, which of the following statements is not correct?

With respect to operators working in a clean room, consider the following statements:
1) Operators should work downstream of the air flow in order not to interrupt the airflow from the inlet to the work area
2) Operators should move quickly with minimal movement and conversation in order to reduce the potential for contamination
3) The source of bacteria in a clean room is from personnel; exhaling, speaking, coughing and sneezing can all contribute to bacterial contamination

Which of the following are used as water immiscible vehicles in the formulation
of parenteral preparations:

According to the BP, which of the following preparations should contain an
antimicrobial preservative, unless otherwise justified:

The procedure of passing a volume of culture medium containing
Pseudomonas diminuta through a filter, followed by incubation and observation
of the culture medium is:

In radiation sterilization:

With respect to gaseous sterilisation, which one of the following statements is
correct:

Which of the following sequences of validation procedures describes the
overall validation process in the correct order:

With respect to validation equipment/indicators, Browne's tubes can be
considered as:

Eye preparations are required to be sterile because:

Isotonicity is desirable for parenteral and ophthalmic products because:

With respect to moist heat sterilisation, which of the following statements is
correct?

Which of the following statements is correct?

With respect to dry heat sterilisation, which of the following statements is not
correct?

Which of the following statements is correct?

Which of the following statements is not correct?

Choose the correct statement: The absorbed dose to tissue is:

Gamma cameras in nuclear medicine are used for?

Choose the false statement:

Which of the following statements is (are) true? The half-life of a radioisotope:
1. is the time for half the number of radioactive nuclei to decay.
2. depends on temperature.
3. is the time for the decay rate to double.

Which of the following statements is false? Regarding positron emission
tomography (PET):

Radiochemical purity of a radioisotope can be detected by:

With respect to particulate contamination, which of the following statements is incorrect:

With respect to the preservative efficacy test, which of the following statements is correct:

With respect to total parenteral nutrition (TPN), consider the following statements
1) Amino acid solutions from different manufacturers can vary in pH, and pH of the final TPN solution can affect the stability of the lipid droplets.
2) Dibasic calcium phosphate is less soluble than the monobasic form and at greater risk of precipitation
3) TPN bag sizes can vary from 250 ml (neonate) to 3000 ml

With respect to the EMA “Decision trees for the selection of sterilistation methods” guidance document, consider the following statements:

1). If a non-aqueous liquid product can be sterilised using dry heat sterilisation at 160°C for 120 minutes, but an alternative combination of time and temperature using dry heat sterilisation could also achieve a sterility assurance level of ≤10-6, either this alternative combination or dry heat at 160°C for 120 minutes may be used for sterilisation of this product.

2) In order to use radiation sterilisation, a minimum absorbed dose of ≥ 35 kGy must first be considered before exploring the validation of other irradiation doses for sterilisation

3) If an aqueous product cannot be sterilised to give an F0 ≥ 8 minutes using moist sterilisation in any time/temperature combination, filtration sterilisation should then be considered.
Considering statements 1-3 above,