USP 797 Clean Room Training – Aseptic Manipulations Skills
Pharmacists engaged in compounding sterile products in compliance with USP Chapter 797 must demonstrate aseptic manipulation skills. To ensure everyone follows the same procedures and protocols, facilities may choose to post a checklist that covers all the key elements of proper aseptic technique.
According to Eric Kastango, RPh, MBA, FASHP, pharmacists and technicians should:1
- Review all orders and verify that all ingredient packages contain the specified ingredients and amounts.
- Cover shoes, hair and beard.
- Put on mask.
- Wash hands with soap and water for at least 30 seconds.
- Don gown.
- Apply a persistent antimicrobial scrub that contains 1% chlorhexidine and 62% alcohol.
- Don sterile gloves, once hands have dried completely, using proper technique.
- Properly clean and disinfect the work surface before and after each batch of compounded sterile product.
- Disinfect with sterile 70% isopropyl alcohol (IPA) all components prior to placement in the ISO Class 5 primary engineering control.
- Disinfection with sterile IPA all critical sites, such as vial septa, syringes, needle hubs and injection ports.
- Use sterile 70% isopropyl alcohol to regularly disinfect gloves. Check gloves for tears and replace as needed.
- Examine each compounded sterile preparation (CSP) to ensure that particulate matter has not gotten into solutions, that vials and bags are not leaking, and that all labels are complete.
Pharmacists or technicians employing aseptic technique to compound sterile products must do so within an ISO Class 5 primary engineering control. Critical sites should be exposed to “first air,” which is unidirectional HEPA-filtered air without particulate contaminants. All activities should occur in the direct first air stream.
Outside the pharmacy
Other healthcare professionals may also undertake CSP preparation using aseptic technique, outside an ISO Class 5 primary engineering control. These individuals should:
- Perform appropriate hand hygiene.
- Disinfect all work surfaces.
- Disinfect all critical sites with sterile 70% isopropyl alcohol before penetrating the container.
- Whenever possible, properly garb before using a sterile needle and syringe to administer or prepare a fluid or medication.
- Use new needles and syringes for each patient and each time a multi-dose vial is used.
- Avoid contamination of the needle and syringe between removing from sterile packaging and use.
- Use single-dose vials whenever possible.
- Label multi-use vials with date of opening and discard within 28 days or the time specified by the manufacturer.
- Refrigerate multi-use vials after opening, if indicated by manufacturer.
- Do not use any package that appears to be contaminated, out of date or compromised in any way. Discard such containers immediately.
- Do not consolidate contents from multiple single-use vials for use on another occasion.
- Do not leave a needle in the vial diaphragm.
By adopting these checklists, facilities can prevent microbial contamination of CSPs.
How has your facility promoted good aseptic technique?
- Kastango ES. Spread the Word: Aseptic Technique Prevents Infection. Hospital Acquired Infections. Pharmacy Purchasing and Products. April 2009.