CASE STUDY
www.baxter.com
15. USE OF CONVENTIONALLY
MANUFACTURED PRODUCTS
AS COMPONENTS
15.1 Use of Conventionally Manufactured
Single-Dose Containers
A conventionally manufactured single-dose
container is a container closure system
that holds a sterile product for parenteral
administration (injection or infusion) that
is not required to meet the antimicrobial
effectiveness testing requirements. If a
single-dose vial is entered or punctured only
in an ISO Class 5 or cleaner air, it may be
used up to 12 h after initial entry or puncture
as long as the labeled storage requirements
during that 12-h period are maintained.
Opened single-dose ampules must
not be stored for any time period.
15.3 Use of Conventionally Manufactured
Pharmacy Bulk Packages
A conventionally manufactured pharmacy
bulk package is a container of a sterile
product for parenteral use that contains
many single doses. The contents are
intended for use in a pharmacy admixture
program and are restricted to the sterile
preparation of admixtures for infusion
or, through a sterile transfer device, for
the filling of empty sterile containers.
The pharmacy bulk package must be
used according to the manufacturer’s
labeling (see <659>, General Definitions,
Injection Packaging Systems). The
pharmacy bulk package must be entered
or punctured only in an ISO Class 5 PEC.
“Work in Progress”
products and labels
can also automate
BUDs for single dose
products, multiple
dose products and
pharmacy bulk
packages used
during preparation
18. QUALITY ASSURANCE AND QUALITY
CONTROL
18.1 Notification About and Recall of Out-of-
Specification Dispensed CSPs
If a CSP is dispensed or administered before
the results of release testing are known, the
facility must have procedures in place to:
• Immediately notify the prescriber of
a failure of specifications with the
potential to cause patient harm (e.g.,
sterility, strength, purity, bacterial
endotoxin, or other quality attributes)
• Recall any unused dispensed
CSPs and quarantine any stock
remaining in the pharmacy.
• Determine the distribution of any
affected CSP, including the date
and quantity of distribution.
• Identify patients who have
received the CSP.
Lot number tracking
can be used to
trace products
and components
to individual
patient doses.
CONCLUSION
The safety, efficiency, and waste-reduction benefits with the use
of IVWFM systems are well-established. ISMP has put forth much
effort in defining what an effective system should be capable of and
recommending their use among other technologies in the cleanroom.
Although IVWFM systems are only used in a minority
of facilities, that number continues to grow due to an
ever-increasing focus on safety and efficiency.
With the updated version of USP <797> effective on November
1, 2023, there is also a heightened interest in what facilities
need to do to become compliant before the effective date.
IVWFM systems with broad functionality such as the
DoseEdge system, can help support pharmacies in their
pursuit of regulatory compliance, optimized workflows,
compounding efficiency, and most of all, patient safety.
The DoseEdge System is not intended to replace the knowledge,
judgment or expertise of pharmacists and pharmacy technicians
in the preparation of IV admixtures or oral doses.
For safe and proper use of the product mentioned herein,
please refer to the appropriate Operator's Manual.
References
1. Stephen F Eckel, et al. Multicenter study to evaluate the benefits of technology-assisted workflow
on i.v. room efficiency, costs, and safety, American Journal of Health-System Pharmacy, Volume 76,
Issue 12, 15 June 2019, Pages 895–901.
2. Elizabeth Flynn, et al. Observational study of accuracy in compounding i.v. admixtures at five
hospitals, American Journal of Health-System Pharmacy, Volume 54, 15 April 1997, Pages 904-12.
3. ISMP Medication Safety Alert Newsletter October 22, 2020 Volume 25, Issue 21. Pg 1-5
4. Pharmaceutical compounding—sterile preparations (general information chapter 797). In: The
United States Pharmacopeia, 35th rev., and the National Formulary, 30 ed. Rockville, MD: The United
States Pharmacopeial Convention; 2012: pp 2-38 State of Pharmacy Compounding.
5. Pharmaceutical compounding—sterile preparations (general information chapter 797). In: The
United States Pharmacopeia, https://online.uspnf.com/uspnf/document/1_GUID-A4CAAA8B-6F02-
4AB8-8628-09E102CBD703_7_en-US35th rev.pp 1-33
6. Pharmacy Purchasing and Products, 2023; 4:1-53 National Survey (Can’t get fill reference info)
7. ISMP Targeted Medication Safety Best Practices for Hospitals, 2022-2023
8. 2022 ISMP Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding
Technology
Baxter and DoseEdge are trademarks of Baxter International Inc.
US-MD14-230014 v1.0 10/2023
Chuck Ferris, R.Ph.
Associate Director, Medical Affairs
~ Baxter Healthcare Corporation
Jeff Brittain, PharmD, BCPS
Senior Manager, Medical Affairs
~ Baxter Healthcare Corporation