King Saud University
College of Pharmacy
Department of Pharmaceutics
Sterile Preparations
434 PHT
5-Group activity fileSupervised by ; Dr. Omaimah Jawharey
Done by:
Abrar Samman
Alaa ALHamdi
Ahlam ALThubati
ALanoud ALThuib
Hanouf ALHuider
Jouri Alanazi
Reem ALSehebani
Reham ALDekhial
Shaima’a Kutbi
Noura ALOlyani
‫بسم هللا الرحمن الرحيم‬
True or false:
1-The sterile products must be prepared , sterilized , and packaged in an environment free of a particular
mater.
2-Filling area is a room in which solutions is subdivided into its final package.
3- filling area must be maintained as free as possible from particular matter.
4- Filling area can be made free from particulate matter by the use of high efficiency particulate matter
(HEPA) filters.
5- High efficiency particulate matter (HEPA) filters have the capable of removing particles of 0.3
micrometer or greater with efficiency of 99.97%
6-the filtered air coming into filling area is free from both microbial contamination and particulate matter.
7-micrbial contamination present in air usually found on dust and other particulate matter.
8-When air supplied filling area its supplied under positive pressure.
9- Positive pressure means that the air in the critical area having a high pressure than the air in the adjoining
areas, flows outward when doors are opened.
10-Positive pressure prevents particulate contamination from sweeing into the critical filling area.
11-The critical filling area is constructed from materials that are easily be cleaned and disinfected.
12- The walls of filling area can be stainless steel or regular wall material covered with epoxy resin paint.
13-The work surface and floor of filling area are smooth and free of cracks and cervices.
14-To insure the disinfection of all surfaces and to maintain sterility once personal have entered the room
the entire room can be irradiated with UV lambs.
15- also person must be protected from UV while they are working in the are.
16-Dr.Willis Whitefield was the one who developed the concept of laminar air flow to improve on
conventional clean rooms.
17-The concept of laminar air flow is a bank of filtered air that moves through a work area in a parallel
configuration and at sufficient speed to sweep contamination with it and create a minimum of turbulence.
18- Laminar flow is defined as: air flow in which the entire body of air within a confined space moves with
uniform velocity along parallel with a minimum of eddies.
19- the velocity of the air flow for effective laminar air flow is usually stated as (90+20) feet per minute
through the undistributed room area.
20-laminar air flow unit have been placed above filling machine.
21-in horizontal flow the HEPA filtered is located at the back of the hood and the air flows to the front.
22-the major disadvantage of horizontal hood is that it offers no protection to the operator .
23- in vertical flow the air passes through HEPA filtered located in the top of the cabinet and is exhausted
through a greated area around the working surface of the hood.
24- the major advantage over horizontal flow hood that the air flow is vertical flowing down on the work
space. This air flow pattern protects the operator against potential hazards from the products being prepared.
25- major advantage over horizontal flow hood that it has larger working area.
26-clean room have been classified in particle count into three groups (the maximum allowance of particles
permissible is 0.5 micrometer and larger os 5 micrometer)
27-Before being used to package sterile products , glass and rubbe components ae washed and sterilized
28- group of empty glass containers are wrapped tightly together with plastic film before shipment , thus
eliminating the contact of the glass with cardboard carbon.
29- the expansion and contraction of the glass break down films and allow steam to penetrate and clean the
surface .
30-it is called ( shock treatment )
31-The glass containers are placed in stainless steel boxes and rendered pyrogen-free and sterile by dry heat
32-To prevent contamination, handling area of wet containers is maintained under vertical laminar air flow
33-The fluoride treatment in the wash cycle is more effective for removing particulate matter
34-As method of sterilization, dry heat is NOT effective as efficient as moist heat (T).. b/c high temp. and
longer time of exposure is required.
35-dry heat is MORE effective for oxidation or "burning up" , and for chemicals and oils which provide
temp below their decomposition temp
36-Ovens usually have circulating air-forced heat, glass containers heated at 180 c for 4 hours.
37-Plastic containers are usually wrapped in filtered air then suitably wrapped and sterilized with ethylene
oxide.
38-The advantage of ethylene oxide that the gas owing to its ability to diffuse and penetrate.
39-heat stable are clarified ,subdivided ,sealed and subjected to terminal sterilization by autoclave.
40-the glass containers are allowed to remain in contact with fluoride solution for approximately 30 second
before the solution is rinse away.
41-Pull -sealing is preferred in large scale operations .
42-Autoclaving is the most widely used and most reliable sterilization method .
43-“Lag time “ is the time required for the autoclave and the contents to reach the sterilization temperature .
44-It's important that indicators be distributed throughout the load to demonstrate the proper heating
conditions have been reached .
45-The most reliable and precise sterilization indicators are thermocouples .
46-Sealed ampuls are routinely tested for proper sealing through the leaker test .
47-Physical & microbiologic methods are used for determining vial-closure integrity .
Choose the correct answer:
1.The critical requirements in overall processing :
a.preparation of the filing area.
b.The procedures of washing and sterilizing the packaging components.
c.The preparation of the personal who fill or subdivided the product into its final package.
d.All of the above
2.Microbial content of the ambient air can be determined by : (viable )
a-Settle plates
b-Andeson sampler
c-Reynier slit air sampler
d-All the above .
3.consist of open petri dishes containing sterile nutrient agar :
a-settle plate
b-Andeson sampler
c-Reynier slit air sampler
4.the disadvantage of Settle plates are:
a-only large particles settle rapidly
b-the volume of air sampled is not known
c- difficult method
d-A and B.
5.which of the following is fuels about mechanical air sampling device :
a-drawbacks of settle plate is avoided
b- air is drawn through these instrument at a specific volume
c-the result expressed as the number of colonies per cubic foot
d-the result expressed as the percent of colonies in a whole sample
6.which of the following is fuels about nonviable particulates :
a-counted by electronic devices such as Royco particle counter
b-cleaning procedure are the most importance the low level of contamination
c- HEPA filters located in hoods, walls , or ceiling must be routinely monitored for presence of cracks .
d- non of the above .
7.regarding to personnel which of the following is true :
a. are the greatest source of particulate matter and possible microbial contamination
b .the foot are covered with disposable boots
c. the clothing are most satisfactory when made from monofailament fabric such as Ty-Vek, which don’t
shed lint or fibers
d. all the above
8.The washing consists of following steps:
1. Outside, rinse with steam >> Inside, rinse with steam.
2. Outside, rinse with filtered water >> Inside, rinse with filtered water
9.The containers are washed with ….......... or ……….. :
a. diluted hydrofluoric acid , ammonium bifluoride
10.Which variables must be considered in using dry heat sterilization :
a. size of oven
b. size of load
c. arrangement of load
d. nature of material being sterilized
e. ALL of the above
11. Regarding Rubber Component, what are the methods of preparation :
a.
Gently agitating the closures in a mild detergent.
b.
Autoclaving the closures immersed in water for injection several times.
c.
Autoclaving the wet closures in sealed package and drying at low heat.
d.
Autoclaving using moist heat under pressure.
e.
ALL of the above
Filtration media can be classified into :
a. depth filters and screen filters.
12.Regarding depth filters :
a. made of asbestos
b. glass and unglazed porcelain
c. it is represent the older groups of filters
d. ALL of the above
13.Regarding Screen or membrane filters:
a. Made of cellulose esters, microfilaments, polycarbonate, synthetic polymers, silver or stainless steel.
b. The film Have mesh work of millions microcapillary uniformed pores
c. The size of pores is 0.45 micro m to remove microorganisms
d. ALL of the above
14.In the screen method, the stems are sealed by:
a. fusion of glass
b. tip-sealing
c. pull-sealing
d. ALL of the above
15.Variables that must be considered in determining the lag time include :
a- size of the autoclave.
b- the nature of the material in the load
c-the manner in which the material is arranged in the autoclave
d- all of the above
16.Control used by industrial to ensure that the product is meet the claim include :
a-Ph specification
b- pyrogen test
c- clarity test
d- all of the above
17. Sterility method that used in case the parenteral product contain a bacteriostatic agent is:
a. The direct transfer of the sample to sterile culture media.
b. Membrane transfer procedure.
18. Sterility method that involve negative and positive control which prepared along with the samples
is:
a.The direct transfer of the sample to sterile culture media.
b. Membrane transfer procedure.
19. Changes in the toxicity of the preparation can come from many sources including:
a.
b.
c.
d.
Raw materials used
Packaging components
Errors made during the compound of solution.
All of the above.
20. The label of parenteral products must indicate all of the following except :
a.The Vehicle used (of other than water).
b.Type of the container .
c.Name of the drug.
d.All additives with percentage of each.
e.Expiration date.
Match :
A) class 100 particle counted not to exceed a total of 100 particle (1)
B) class 10 000 particle counted not to exceed a total of 10 000 particle (2)
C) class 100 000 particle counted not to exceed a total of 100 000 particle (3)
1) per cubic foot of a size 0.5 µm and large
2) per cubic foot of a size 5.0 µm and large
3) per cubic foot of a size 0.5 µm and large OR 700 particles per cubic foot of size 5.0
and large
µm