Sterile Dosage Forms

Question 1

What are the must have characteristics of parenterals? what SHOULD they be (isotonic/hypertonic)?

Answer 1

1. Sterile
2. No pyrogens
3. No visible particles
4. Stable
5. Compatible with drugs/excipients

Should be isotonic (CSF = must)

Question 2

Define tonicity
Which type of solutions affect tonicity?(permeable/impermeable)

Answer 2

Tonicity
- measure of effective osmotic concentration across a semi permeable

Impermeable: AFFECT TONICITY
permeable: do NOT affect tonicity

Question 3

Explain what happens to the cell in:
Hypertonic
Isotonic
Hypotonic

Answer 3

Hypertonic: water out = cells shrivel
Isotonic: equal
Hypotonic: water in: cells burst

Question 4

What injection has the fastest onset? Why?

Answer 4

Intramuscular
- more blood vessels
- good for drugs with low bioavailability

Question 5

Which IV infusions is the quickest? How often must they be removed

Answer 5

Peripheral IV line
- removed every 72-96 hours

Question 6

Where is a central catheter inserted in? When is it used? Risks?

Answer 6

Inserted into central vein
- tolerate larger osmotic differences due to rapid dilution of drug (chemotherapy)
- long-term use
Risks: infections, thrombosis formation

Question 7

When is cerebrospinal fluid injection CSF (epidural) used? What are conditions

Answer 7

injected in epidural space of CSF
used to bypass BBB
- preservative free, isotonic

Question 8

Where is intrathecal injection placed?

Answer 8

injected into subarachnoid space of spinal chord to bypass BBB

Question 9

What are some things that can be used to create sterile product areas?

Answer 9

Physical barriers
HEPA
Airflow
Pressure

Question 10

What is the direct compounding area?

Answer 10

CLEANEST area; where critical sites are exposed to air first

Question 11

What type of ISO class is in the primary engineering control? What does HEPA filter prodivde

Answer 11

ISO class 5
low ISO class = cleaner

Question 12

Explain laminar air flow. Differentiate between vertical and horizontal

Answer 12

First air
- prevents contamination of sterile compounds
- NOT protect user
- NON-hazardous material only

Adjusts orientation of products to make sure they are getting air first

Question 13

Explain biological safety cabinet. What does Class II do?

Answer 13

• prevent contamination of sterile compounds
• PROTECTS USER
• GOOD for hazardous material

Question 14

Explain secondary engineering controls SEC

Answer 14

additional cleanliness measures
- increase air supply, HEPA, pressure
- (more rooms outside of the PEC) ex. buffer room, ante room

Question 15

Features of the buffer room (SEC)
ISO
PEC or no?
ACPH

Answer 15

ISO 7+
Contains PEC
Minimum ACPH

Question 16

Features of the ante room (SEC)
ISO
PEC or no?

Answer 16

ISO 8+
no PEC
For high particulate matter levels

Question 17

Pressure (positive/negative) for nonhazardous & hazardous material:

Buffer to ante
Ante to non controlled (outside)

Answer 17

Non-Hazardous
Buffer to ante: positive
Ante to non controlled (outside): positive

Hazardous
Buffer to ante: NEGATIVE
Ante to non controlled (outside): positive

Question 18

What are large volume parenterals (100mL+) for? Small volume (<100mL)

Answer 18

Large volume
- replacing fluids
- continuous infusion (pump)

Small volume
- includes IV bags and syringes
- usually have mediation
- admin for over 5-180 min

Question 19

What is added to powdered drug before going into an IV bag?

Answer 19

Sterile water for injection

Question 20

Define powder volume

Answer 20

volume a powder drug occupies AFTER being reconstituted with SWFI
- only important for partial dose

Question 21

Where does dressing occur in drug preparation?

Answer 21

in the ante room

Question 22

What is the safest method for removing medication from vial?

Answer 22

Negative pressure: volume of air added to vial is less than volume of solution removed

Question 23

Methods of sterilization:
Describe autoclave. What its use?
How to test?

Answer 23

Water used to create steam in high pressure
- used to kill microorganisms

Used to sterilize equipment
- eg. mops to clean room

Test: on bacterial spore (bacillus)

Question 24

Methods of sterilization:
Describe dry-heat sterilizaiton/depyrogenation. What its use?
How to test?

Answer 24

Dry heat dehydrates and burns (oxidizes) organisms

Used for powders & heat stable items

Test: on amount of pyrogen. Must reduce by 3 log reduction

Question 25

Methods of sterilization:
Describe gas sterilization. What its use?
How to test?

Answer 25

Pressure & vacuum chamber fills with gas
- alkylating agent interfering with cell metabolism

Used for materials that cannot withstand high temperature (plastic)

Test: use biological indicator (bacillus)

Question 26

Methods of sterilization:
Describe ionizing radiation. What its use?
How to test? Explain gamma and beta radiation

Answer 26

Radiation ionizes water forming free radicals

Used for products that cannot withstand heat, ingestible products

Gamma: slow, deep penetration
Beta: Fast, shallow penetration

Question 27

Methods of sterilization:
Describe sterilization by filtration. What its use?
Size?

Answer 27

Remove microorganisms physically (does not remove pyrogens)

Must use a 0.22 microm or SMALLER

Question 28

What is the BUD for punctured single dose vials in ISO 5? ISO 5+?

Answer 28

Punctured in ISO class 5: BUD=6 hours
Punctures in ISO class 5+: BUD = 1 hour

Question 29

What is the BUD for puncturing multi dose vials?

Answer 29

always 28 days

Question 30

What does a lower storage temp indicate for BUD

Answer 30

lower BUD

Question 31

Contamination level risk in NAPRA (sterile units)
Low
Medium
High

Answer 31

Low: up to 3 sterile units
Medium: 4 sterile units
High: non-sterile ingredients

Question 32

What are features of controlled environment storage

Answer 32

Temp (during transportation too)
○ Controlled room temp: 15-20C
○ Refrigerator: 2-8C
No light
- Humidity: <60%