Terminology used in pharmacy cleanrooms and compounding sterile preparations includes: [1] CSP (Compounded Sterile Preparation) refers to sterile drug products prepared by compounding in a sterile environment. These are the items prepared in pharmacy I.V. rooms. [2] USP, ISO, and other organizations set standards for cleanliness and quality of sterile compounding areas and processes. [3] Key areas of a cleanroom include the Ante-Area for garbing and staging, the Buffer Area where sterile compounding takes place, and the PEC (Primary Engineering Control) which provides the ISO Class 5 environment.

1. Important Pharmacy Cleanroom
Terminology

2. There are many terms used when
compounding sterile medications in
a pharmacy “I.V. room”

3. We’ll start with the basics and
go from there…

4. CSPCompounded Sterile Preparation
A sterile drug product that has been prepared by compounding
by a qualified individual in a sterile environment.
These are the items prepared in pharmacy “I.V. rooms”

5. USPThe United States Pharmacopeial Convention
A scientific nonprofit organization that sets standards for
the identity, strength, quality, and purity of medicines,
food ingredients, and dietary supplements manufactured,
distributed and consumed worldwide.

6. USP <797>The chapter in the United States Pharmacopeia and The
National Formulary (USP-NF) that provides procedures
and requirements for compounding sterile preparations.
Also known as ‘USP General Chapter <797>’

7. ISOInternational Organization for Standardization
An independent, non-governmental membership
organization and the world's largest developer of
voluntary international standards. ISO standards are used
to define the “cleanliness” of pharmacy I.V. rooms.

8. ISO ClassISO Class defines the level of airborne particulate
cleanliness applicable to a cleanroom. The ISO Class
represents the maximum allowable concentrations of
particles per cubic meter of air for considered sizes of
particles. The lower the ISO Class number, the fewer
particles per cubic meter of air, i.e. lower is “cleaner”

9. Ante-AreaISO Class 8 or better area where personnel hand hygiene
and garbing procedures, staging of components, order
entry, CSP labeling, and other high-particulate-generating
activities are performed.
No compounding is performed in the Ante-Area

10. Buffer AreaAn area where the primary engineering control is
physically located. This is where sterile
compounding takes place.
Also known as the “cleanroom”

11. CleanroomA room in which the concentration of airborne particles is
controlled to meet a specified airborne particulate
cleanliness class. Microorganisms in the environment are
monitored so that a microbial level for air, surface, and
personnel gear are not exceeded for a specified
cleanliness class.

12. Segregated
Compounding Area
A designated space, either a demarcated area or room, that
is restricted to preparing low-risk level CSPs with 12-hour or
less Beyond-Use Date (BUD).

13. PECPrimary Engineering Control
Device or room that provides an ISO Class 5 environment for
exposure of critical sites when compounding CSPs. Devices
include laminar airflow workbenches (LAFWs), biological safety
cabinets (BSCs), compounding aseptic isolators (CAIs), and
compounding aseptic containment isolators (CACIs).
In most pharmacy cleanrooms the “hoods” are the PEC

14. PPEPersonal Protective Equipment
Equipment worn to minimize exposure to a variety of
hazards. Examples of PPE include such items as gloves,
foot and eye protection, protective hearing devices
(earplugs, muffs) hard hats, respirators and full body suits.

15. BUDThe date or time after which a CSP shall not be stored or
transported. The date is determined from the date or time
the CSPs preparation is compounded.
This is not the manufacturer’s expiration date

16. Exp Date
Expiration Date
The date, usually placed on the containers/labels of the Active
Pharmaceutical Ingredient (API), designating the time during
which the API is expected to remain within established shelf-life
specifications if stored under defined conditions. The exp date is
provided by the manufacturer.

17. Media-Fill Test
A test used to qualify aseptic technique of compounding
personnel and to ensure that the processes used are able to
produce sterile products without microbial contamination.
During this test, a microbiological growth medium such as
Soybean–Casein Digest Medium is substituted for the actual
drug product to simulate admixture compounding.

18. JERRY FAHRNI, PHARM.D.