Dec 07, 2016
In making compounded sterile preparations (CSPs), International Standards highly recommend the use of primary engineering controls (PECs). A PEC is a device or room that provides an ISO Class 5 or Grade A environment for compounding of CSPs. While it can be a room, it is commonly an equipment that is certified to standards.
PECs rely on high-efficiency particulate air (HEPA) filters to maintain ISO Class 5 air. HEPA filters are > 99.995% efficient at removing particles as small as 0.3 microns. The unidirectional HEPA-filtered air provides enough velocity to sweep away particles from the Direct Compounding Area (DCA) and maintain unidirectional flow during the preparation of CSPs.
There are a variety of PECs used in sterile pharmacy compounding. Their applicability depends on which type of CSP will be prepared.
Type of CSP
Total parenteral nutrition, ophthalmic preparations, central IV admixtures
|Antineoplastic agents, hormones, antibody drug conjugates|
|Objective/s||1. To protect the product from microbial and cross-contamination||
1. To protect the product from microbial and cross contamination
2. To protect the personnel and environment against these HDs
1. Laminar Flow Clean Benches
2. Class II Biological Safety Cabinet
3. Compounding Aseptic Isolators (CAIs)
4. Positive-pressure Isolators
1. Cytotoxic Drug Safety Cabinets
2. Class II Biological Safety Cabinets
3. Compounding Aseptic Containment Isolators (CACI)
4. Negative-pressure Isolators
"Proper location of the PEC is also critical. The equipment should be placed appropriately, or else, contamination may be introduced to the CSPs you are compounding."
Isolators, in general, provide better protection compared to "open front" cabinets. The ability of "open front" cabinets in maintaining ISO Class 5 environment at all times is heavily dependent on 1) cabinet placement, 2) operator technique, 3) environmental factors. Isolators, on the other hand, are not easily affected by the above factors.
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