Sterile Dosage Forms Flashcards
What are the must have characteristics of parenterals? what SHOULD they be (isotonic/hypertonic)?
- Sterile
- No pyrogens
- No visible particles
- Stable
- Compatible with drugs/excipients
Should be isotonic (CSF = must)
Define tonicity
Which type of solutions affect tonicity?(permeable/impermeable)
Tonicity
- measure of effective osmotic concentration across a semi permeable
Impermeable: AFFECT TONICITY
permeable: do NOT affect tonicity
Explain what happens to the cell in:
Hypertonic
Isotonic
Hypotonic
Hypertonic: water out = cells shrivel
Isotonic: equal
Hypotonic: water in: cells burst
What injection has the fastest onset? Why?
Intramuscular
- more blood vessels
- good for drugs with low bioavailability
Which IV infusions is the quickest? How often must they be removed
Peripheral IV line
- removed every 72-96 hours
Where is a central catheter inserted in? When is it used? Risks?
Inserted into central vein
- tolerate larger osmotic differences due to rapid dilution of drug (chemotherapy)
- long-term use
Risks: infections, thrombosis formation
When is cerebrospinal fluid injection CSF (epidural) used? What are conditions
injected in epidural space of CSF
used to bypass BBB
- preservative free, isotonic
Where is intrathecal injection placed?
injected into subarachnoid space of spinal chord to bypass BBB
What are some things that can be used to create sterile product areas?
Physical barriers
HEPA
Airflow
Pressure
What is the direct compounding area?
CLEANEST area; where critical sites are exposed to air first
What type of ISO class is in the primary engineering control? What does HEPA filter prodivde
ISO class 5
low ISO class = cleaner
Explain laminar air flow. Differentiate between vertical and horizontal
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
Explain biological safety cabinet. What does Class II do?
- prevent contamination of sterile compounds
- PROTECTS USER
- GOOD for hazardous material
Explain secondary engineering controls SEC
additional cleanliness measures
- increase air supply, HEPA, pressure
- (more rooms outside of the PEC) ex. buffer room, ante room
Features of the buffer room (SEC)
ISO
PEC or no?
ACPH
ISO 7+
Contains PEC
Minimum ACPH
Features of the ante room (SEC)
ISO
PEC or no?
ISO 8+
no PEC
For high particulate matter levels
Pressure (positive/negative) for nonhazardous & hazardous material:
Buffer to ante
Ante to non controlled (outside)
Non-Hazardous
Buffer to ante: positive
Ante to non controlled (outside): positive
Hazardous
Buffer to ante: NEGATIVE
Ante to non controlled (outside): positive
What are large volume parenterals (100mL+) for? Small volume (<100mL)
Large volume
- replacing fluids
- continuous infusion (pump)
Small volume
- includes IV bags and syringes
- usually have mediation
- admin for over 5-180 min
What is added to powdered drug before going into an IV bag?
Sterile water for injection
Define powder volume
volume a powder drug occupies AFTER being reconstituted with SWFI
- only important for partial dose
Where does dressing occur in drug preparation?
in the ante room
What is the safest method for removing medication from vial?
Negative pressure: volume of air added to vial is less than volume of solution removed
Methods of sterilization:
Describe autoclave. What its use?
How to test?
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)
Methods of sterilization:
Describe dry-heat sterilizaiton/depyrogenation. What its use?
How to test?
Dry heat dehydrates and burns (oxidizes) organisms
Used for powders & heat stable items
Test: on amount of pyrogen. Must reduce by 3 log reduction
Methods of sterilization:
Describe gas sterilization. What its use?
How to test?
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)
Methods of sterilization:
Describe ionizing radiation. What its use?
How to test? Explain gamma and beta radiation
Radiation ionizes water forming free radicals
Used for products that cannot withstand heat, ingestible products
Gamma: slow, deep penetration
Beta: Fast, shallow penetration
Methods of sterilization:
Describe sterilization by filtration. What its use?
Size?
Remove microorganisms physically (does not remove pyrogens)
Must use a 0.22 microm or SMALLER
What is the BUD for punctured single dose vials in ISO 5? ISO 5+?
Punctured in ISO class 5: BUD=6 hours
Punctures in ISO class 5+: BUD = 1 hour
What is the BUD for puncturing multi dose vials?
always 28 days
What does a lower storage temp indicate for BUD
lower BUD
Contamination level risk in NAPRA (sterile units)
Low
Medium
High
Low: up to 3 sterile units
Medium: 4 sterile units
High: non-sterile ingredients
What are features of controlled environment storage
Temp (during transportation too)
○ Controlled room temp: 15-20C
○ Refrigerator: 2-8C
No light
- Humidity: <60%
