Sterile Compounding

Question 1

USP 797

Answer 1

Pharmaceutical Compounding - STERILE PRODUCTS

Conventional Pharmacies & Hospital Pharmacies

Question 2

USP 797 Focus 3 Areas

Answer 2

• *CSP HANDLING & COMPOUNDING —_ _CONDITIONS**
• *low - medium - high risk**
• *BUD** = beyond use date
• *ENVIRONMENTAL REQUIREMENTS**
• *faciliy design** / air quality / monitoring / environment

PERSONNEL REQUIREMENTS
training etc / documentation

Question 3

Initial RX Evaluation

Answer 3

pH changes

Divalent Cations = Calcium/Mag
Divalent Anions = Carbonate/citrate / Phosphate

Calcium - Phosphate Precipitation

AA –> bind drugs

Light exposture

Ion Pairs

Adsorb drugs –> fiters

Question 4

Low-Risk Level CSPs

RISK OF CONTAMINATION AND BEYOND USE DATES (BUD)

Room Temp = 48 hours

Fridge = 14 days

frozen for all = 45 days

Answer 4

CLASS 100 area
ALl activities- sterile ingredient / product / etc
not all under aseptic condtions

no more than < 3 commercial products

NMT <2 Transfers

Question 5

Medium Risk Level CSPs

RISK OF CONTAMINATION AND BEYOND USE DATES (BUD)

Room Temp = 30 hours

Fridge = 9 days

all = 45 days frozen

Answer 5

MULTIPLE Individual vials are COMBINED

TPN >> Vials >> TRANSFERS

Question 6

HIGH Risk Level CSPs

RISK OF CONTAMINATION AND BEYOND USE DATES (BUD)

Room Temp = 24 hours

Fridge = 3 days

all = 45 days frozen

Answer 6

Non-Sterile ingredients for PREP

< 100 Class air

PROCEDURE > 1 HOUR

Question 7

ISO CLASSES

Ante Room

Buffer Room

LAW

Answer 7

Highest Number = DIRTIEST

ISO 8 = Class 10k

Iso 7 = Class 1k

LAW = ISO 5 = Class 100

Question 8

Room Air FLow

Chemo / Hazard
Vs
Convnetional LVP IV

Answer 8

NEGATIVE PRESSURE
to retain chemo drug in room

Positive for conventional LVP IV

Question 9

CACI

CAI

Answer 9

• *CACI = NEGATIVE**
• *Containment**

CAI = Compounding Aseptic Isolator
positive air flow

Question 10

• Restricted Access Barrier Systems (RABS) – “glove box” – Containment systems

Answer 10

• Smaller
• Clear separation of problem areas
• Fewer engineering controls
• Minimal human involvement
• Less reliance on procedures

More difficult cleaning

Question 11

TPN / PN Considerations

As pH DECREASES:

As amino acid content increases:

Answer 11

• Calcium phosphate solubility increases
• IV fat emulsion physical stability decreases
• • As amino acid content increases,
• ph decreases* –> Ca-P solubility INCREASES

Question 12

TRASH

Answer 12

RED = SHARPS

YELLOW = HAZARDOUS / CANCER

Pharmaceutical = Black