(Learning about USP Chapter <800> in 10 minutes a week.)

5. Facilities and Engineering Controls

5.3.2 STERILE Compounding

C-PEC

• All C-PECs for manipulation of sterile HDs must be externally vented.
• The C-PEC must provide an ISO Class 5 or better air quality.
• Class II or III BSC or CACI, Class II BSC types A2, B1, or B2 are okay.
• A LAFW or CAI must not be used for compounding an "antineoplastic" HD.
• A BSC or CACI used for HDs must not be used for non-HDs unless the non-HD preparation is placed in a protective outer wrapper during removal from the C-PEC and is labeled to require PPE handling precautions.
• The C-PEC must be located in a C-SEC; either an ISO Class 7 buffer room with an ISO Class 7 anteroom, OR
• An unclassified containment segregated compounding area (C-SCA). If a C-SCA, all CSPs prepared must be limited as described in <797> for CSPs prepared in a segregated compounding area.
• ISO Class 7 buffer room with ISO Class 7 anteroom
  • Fixed walls.
  • HEPA-filtered supply air.
  • Negative pressure between 0.01 and 0.03 inches of water column (IWC).
  • Minimum 30 air changes per hour (ACPH).
  • Use <797> BUDs based on CSP categories, sterility testing, and storage temperature.
  • Buffer Room must be externally vented.
• Room through which the Buffer room is entered (e.g., anteroom or non-HD buffer room) must have:
  • Minimum 30 ACH of HEPA-filtered supply air.
  • Maintain positive pressure of at least 0.02 IWC.
  • Maintain air quality of ISO Class 7 or better.
• Anteroom ISO Class 7
  • Fixed walls.
  • Hand-washing sink at least 1 meter from entrance to HD buffer room.
• Containment segregated compounding area (C-SCA)
  • Fixed walls.
  • Negative pressure between 0.01 and 0.03 IWC.
  • Minimum of 12 ACPH.
  • Externally vented.
  • Hand-washing sink placed at least 1 meter from C-PEC and may be either inside or directly outside the C-SCA.
  • Only low- and medium-risk HD CSPs may be prepared.
  • BUDs must not exceed <797> CSPS prepared in a segregated compounding area.
• If the negative-pressure HD buffer room is entered through a positive pressure non-HD buffer room the following is required:
  • Line of demarcation within negative-pressure buffer room for donning and doffing PPE.
  • Method of transporting HDs, HD CSPs, and HD waste into and out of negative pressure buffer room (e.g., pass-through between negative pressure buffer area and adjacent space).
  • The above pass-through chamber must be certified to ensure it does not compromise air quality in the negative pressure buffer room.
  • A refrigerator pass-through cannot be used.
  • Other methods of containment (sealed containers) may be used.

NEXT WEEK:
5.3.4 Containment Supplemental Engineering Controls

QUESTIONS RECIEVED FROM PHARMACISTS:
We will be posting valid answers to these questions as they are received. The responses must go through channels, but we will post them as they are received over the next several weeks. The "numbering system" will stay with each question. After the responses are posted on this newsletter, they can also be reviewed from: www.ijpc.com/USP800Questions

Additional questions:

25. Why is it necessary to externally vent the C-PEC for Sterile HD compounding but not for NS HD compounding?
26. Section 5.3.2 specifically states that a LAFW cannot be used for compounding an antineoplastic HD. So, can a LAFW or CAI be used for compounding a non-antineoplastic HD?
27. If a BSC or CACI used for HDs is also used for non-HDs, what must be done after the non-HD preparations is placed in a protective outer wrapper and removed from the C-PEC? Must the wrapper and the non-HD preparation be handled as an HD preparation and the wrapper discarded as hazardous waste?
28. What is meant by "fixed walls"? Must they be totally solid? Can one use a soft-wall system utilizing a solid steel frame affixed to the floor and ceiling since this is "fixed"?
29. Does a "Fixed wall" have to go all the way to the floor?
30. If entering a negative-pressure HD buffer room through the positive-pressure non-HD buffer room and a "line of demarcation" is used to designate the area for donning and doffing PPE, is it critical which way the "air flows" in the buffer room as this will impact the placement of the exhausting air vents?
31. Is it correct that probably the final preparation and administration of most of the C-SCA HD CSPs will be in clinics, hospitals, physician offices, etc.? If so, who will be enforcing these standards?

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

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Did You Know ...

�that unintended consequences (unanticipated consequences or unforeseen consequences) are outcomes that are not the ones foreseen and intended by a purposeful action?

Tip of the Week

Be aware of unintended consequences and be prepared to address them. Unintended consequences can be grouped into three types:

• Unexpected benefit - A positive, unexpected benefit.
• Unexpected drawback - A negative, unexpected detriment occurring in addition to the desired effect of the policy.
• Perverse result - A perverse effect contrary to what was originally intended (when an intended solution makes a problem worse).

Looking Back

In every half pound
My boy,
You get a ton,
Of shaving joy!
     Burma Shave