STERILE

Question 1

Moist heat
(autoclaving, steam sterilization)

Answer 1

Sterilizes by

• *PROTEIN DENATURATION**
• *121*C for 15 min (15psig)**

destroys bacteria & spores, need to remove air

Parenteral products / media / GLASS / STEEL / UTENSILS / Media

Question 2

DRY HEAT

Oven sterilization

Answer 2

DESTROY MICROORGANISMS & PYROGENS

High heat = 160*C

Glass / stainless steal

loss of moisture / protein denaturation / oxidation

Question 3

Non-Thermal Filtration

DRUG SOLUTION

Answer 3

Microbial & Pyrogen Free

0.22 mucron filter

CLASS 100 = ISO 5 ROOM

Question 4

Non-Thermal Filtration

RADIATION STERILIZATION

Answer 4

GAMMA RADIATION

Cobalt 60

to sterilize
IV Admin sets / DISPOSABLE GOWNS / PLASTICS

DNA DESTRUCTION

Question 5

Non-Thermal Filtration​

Room AIR & Laminar Aiflow hood air

Answer 5

PRE FILTERS

0.22 - 0.45 micron filters

flow too high = LEAK / Damage

too LOW = plugged

Question 6

CHEMICAL STERILIZATION

ETHYLENE OXIDE & Other Cemicals

Answer 6

used for
PLASTICS & other disposable medical devices

FASCILITY

ALKYLATION –> block metabolic pathways

Question 7

Pyrogens
Sterilization

from microorganisms / gram - & positive / fungi

induce fever / chills / pain / malaise

Answer 7

can NOT be removed by filtration

need HIGH TEMP sterilization

Question 8

LAL
Limulus Amebocyte Lysate
Coagulation test

Answer 8

TESTED ON RABBITS

for PYROGENS

Question 9

Prefilters & membrane Filter

Size

Air vilocity & # of air changes/time important

Answer 9

0.22 - 0.45 micron

to

remove particulate from AIR

BACTERIA is transported via particulate

Question 10

STABILITY

No significant changes in the product during SHELF LIFE

changes include:

Answer 10

• *Chemical**
• *potency of active ingredient**

Physical

• *Microbiological**
• *sterility**

Biophamaceutic / Therapeutic

Toxicity

Question 11

High Temperature studies can predict WHAT?

Packages must maintain integrity throughout shelf life including normal use (multiple needle punctures in vials).

Answer 11

CHEMICAL CHANGES

but NOT
Physical Changes

Question 12

SVP Products

Answer 12

• Solutions of small molecule drugs
• Solutions of biopharmaceutical drugs
• Suspensions
• Emulsions
• Solids for injection
• Ophthalmics
• Small volume irrigation solutions
• Vaccines
• Radiopharmaceuticals
• Allergenic products
• Others.

Question 13

• Conventional large volume injections (LVP)

Answer 13

• Electrolyte solutions (Normal Saline)
• Carbohydrate solutions (D5W)
• Nutritional proteins and amino acids
• Lipid emulsions
• Peritoneal dialysis solutions
• Irrigation solutions
• Others.

Question 14

• Modified release (depot) injections and medical devices

Answer 14

• Polymeric implants
• Microspheres
• Liposomes
• Others.

Question 15

Special SPECIFICATIONS

for STERILE PRODUCTS

Answer 15

• Potency
• pH
• Sterility
• Particulates
• Preservative content
• Others.

Any changes to formula, process, specifications, labeling, etc. must be approved by the regulatory agency.

Question 16

USP 797

Answer 16

Pharmaceutical Compounding – Sterile Products

Also for HOSPITAL PHARMACIES

• Responsibilities of compounding personnel
• Microbial contamination risk levels
  
  • (low, medium, high) and requirements
• Personnel training and evaluation
• Personnel garbing
• QA // Engineering​

Question 17

USP 800

Answer 17

addresses precautions to be considered with hazardous drugs. NIOSH guidance is basis for USP <800>.

USP <800> is concerned with
protection of hospital workers from exposure to toxic drugs and potential toxic effects.

Question 18

NEW ENGLAND COMPONDING CENTER

Answer 18

DISASTER -> many people died

caused the FDA to be INVOLVED in Pharmaceutical compounding

503A & 503B Pharmacies

A = for specific patients

B = for the market

Question 19

503A Pharmacy

Answer 19

FDA GUIDELINE
after New England event

for
Dosage Forms –> SPECIFIC PATIENTS

Question 20

503B Pharmacies

Answer 20

FDA guideline

Pharmacists prepare
dosage forms per market requiest

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