Compounded Sterile Preparations

Compounded Sterile Preparations

 

Pharmacy play an important role as one of the allied healthcare professions responsible for the preparation and storage of compounded sterile and no sterile preparations also many other important connection within the scope of infection prevention and control activities e.g. participation in the hospital wide antibiotic stewardship, preparation of sterile parenteral fluids (that need to be prepared inside pharmacy using ISO class 5 clean room e.g. laminar airflow hood, pharmacy has to have program for parenteral preparation either if it will be prepared by pharmacy staff or nursing staff using laminar airflow hood with close supervision for the whole process after training program for the staff involved in that process.

Compounded Sterile Preparations

Compounded Sterile Preparations

The parental preparation need to be prepared under complete sterile conditions to prevent any harm to the receiving patient ranging from minor infection to death resulting from : (1) microbial contamination (non sterile ), (2) increase bacterial endotoxins, (3) unintended chemical and physical contaminants, (4) ingredients of inappropriate quality in compounded sterile preparations (CSPs) , compounded sterile preparations (CSPs) are classified into categories based on risk of microbial contamination to all compounded sterile preparations:

Low-Risk Level: CSPs prepared in ISO class 5 air cleanliness conditions located within ISO class 7 or 8 buffer area. The compounding procedure involves simple aseptic manipulations using no more than three commercially available ingredients and not more than two entries into any one final container.

Low-Risk Level With 12-Hour Beyond-Use Dating: CSPs prepared in ISO class 5 air cleanliness conditions in an unclassified segregated compounding area with ambient air.

Medium-Risk Level: CSPs prepared under batch conditions (multiple individual doses) using complex aseptic manipulations (e.g., parenteral nutrition solutions and patient-controlled analgesia prepared in ISO class 5 air cleanliness conditions in an ISO class 7 or 8 area.

High-Risk Level: CSPs prepared from nonsterile ingredients or nonsterile devices used prior to terminal sterilization (e.g., autoclave) or prepared in air quality less than ISO class 5 air cleanliness.

Certain measures need to be applied while preparing the CSP for the environment, personnel …etc. for Personnel preparing CSPs they are required to perform appropriate hand hygiene procedures and wear garb (hair net, beard cover [if applicable], shoe covers, long sleeve gown closed at the collar and knit cuffs and sterile gloves) plus no makeup or nail polish and to keep nail short to keep the maximum clean status when preparing the CSP

When preparing the rubber stoppers of the containers need to be wiped with sterile 70% alcohol as the vial septum is not sterile under the cap and need to be disinfected properly before use (this is applied for all vials before using not only during preparation the CSP)

 

Based on the CDC, FDA recommendations pharmaceutical compounding need environmental sampling as part of comprehensive quality management program for the CSP process Environmental sampling is one important quality assurance procedure required of all compounders (pharmacists, technicians, nurses, physicians, and others) .environmental sampling is doing in the following conditions:

  1. included in commissioning and accrediting of new facilities and equipment
  2. Any servicing of facilities and equipment (e.g. periodic preventive maintenance PPM)
  3. included in the  re-certification of facilities and equipment
  4. In response to identified problems with end products or staff technique (e.g. laboratory confirmed problem for the CSP product)
  5. In response to issues with compounded sterile preparations (CSPs), observed compounding personnel work practices, or patient-related infections where (e.g. outbreak investigation)

Reference

 

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