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Policies,Clinical,UWHC Clinical,Department Specific,Pharmacy,Sterile Products Area (SPA)

Sterile Product Preparation (6.0)

Sterile Product Preparation (6.0) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Sterile Products Area (SPA)

6.0

POLICY & PROCEDURE





Effective Date:
Aug 2014
☒Pharmacy Policy Manual
☐Operations Procedure Manual


Policy: 6.0

☐Original
☒Revision 10/16

Page 1 of 6

Title: Sterile Product Preparation


I. PURPOSE: To provide minimum practice and quality standards for compounded sterile product (CSPs)
preparation across all of UW Health to ensure patient safety and product integrity.
II. POLICY
A. General
1. This policy will apply to all UW Health sterile product preparation locations including:
a. University of Wisconsin Hospital (UWH) Inpatient Pharmacy
b. UWH Nuclear Pharmacy
c. Carbone Cancer Center
d. American Family Children’s Hospital (AFCH) Inpatient Pharmacy
e. The American Center Inpatient Pharmacy
f. 1 South Park Oncology Clinic
2. UW Health Pharmacy will only compound low and medium risk compounded sterile products
(CSP). Products that are considered high risk will not be compounded.
3. Refer to the Pharmacy Operations Manual for instruction on the preparation of compounded
sterile products during any downtime period
B. Controlled access to cleanrooms
1. Rooms used for the preparation of CSPs shall be isolated from other areas with entry and access
restricted to designated personnel and shall be designed to avoid unnecessary traffic and airflow
disturbances.
a. Entry into the clean room shall be limited to trained and scheduled pharmacists,
pharmacy technicians or trained environmental service staff accessing the room to
complete an assigned task.
b. All staff that enters the clean room must be appropriately gowned and garbed.
c. Attempts should be made to minimize the number of compounding staff in the clean
room during shift change to minimize the impact of disruptive airflow.
2. Access to the buffer areas is restricted to properly gowned & garbed qualified personnel with
specific responsibilities or assigned tasks in the compounding area. Traffic flow in/out of buffer
area should be minimized. Technicians not actively compounding should not remain in the buffer
area for any reason.
3. Cleanrooms shall be used only for the preparation and documentation of sterile pharmaceuticals.
a. Non-sterile hazardous products may be prepared in the biological safety cabinet (BSC) or
fume hood with personal protective equipment (PPE) for employee protection when
needed.
b. Additional drug inventory and bulk supplies shall be stored in an area separate from the
designated area for preparing sterile pharmaceuticals.
c. Eating, drinking, chewing gum, candy, mints, and tobacco of any type are strictly
prohibited in the clean room.
C. Cleanroom Maintenance and certification
1. All ISO Class 5 environments must be cleaned and disinfected as follows:
a. The entire ISO Class 5 environment must be cleaned and disinfected at the beginning of
each shift, after disassembling an automated compounding device, after a spill, and/or
anytime visible or suspected contamination occurs.
b. The critical compounding areas must be disinfected before each batch preparation.

POLICY & PROCEDURE





Effective Date:
Aug 2014
☒Pharmacy Policy Manual
☐Operations Procedure Manual


Policy: 6.0

☐Original
☒Revision 10/16

Page 2 of 6

Title: Sterile Product Preparation


c. Cleaning of ISO Class 5 environments must be documented electronically in the online
database for each shift.
2. The following elements in all ISO Class 7 and 8 environments must be completed daily during
area cleaning
a. All horizontal work areas, counter surfaces, sink and outside surfaces of the laminar air
flow hoods must be cleaned.
b. Floors must be mopped starting in the buffer area moving to the ante area.
c. Walls, sills, doors, phone, shelves and any other item in the ISO Class 7 or 8
environments should be spot cleaned as needed in between monthly deep cleaning.
d. Cleaning of ISO Class 7 and 8 environments must be documented electronically in the
online database daily.
3. The following elements in all ISO Class 7 and 8 environments must be completed during area
monthly deep clean
a. All shelving units, drug storage bins, supply bins, and refrigerators must be emptied and
cleaned.
b. All walls and ceilings must be cleaned at least once per month.
c. Cleaning of ISO Class 7 and 8 environments must be documented electronically in the
online database once per month.
4. The hood and HEPA filter shall be inspected and non-viable room air quality (particle counts)
shall be certified semi-annually.
a. Hood and HEPA filter testing will include measures of air velocity, HEPA filter
condition, pre filter condition and leakage.
b. Non-viable room air testing will include particle counts inside each hood, in the critical
areas and in the anteroom.
c. Electronic documentation of this testing will be kept in an online database for a three year
period of time.
5. Each month a measurement of bioburden will be conducted using Enviro-test media paddles by
UWHC Pharmacy staff.
a. Measurements will include air in the hood, the surface of each hood, and the air in the
critical area adjacent to the hood.
b. Electronic documentation of this testing will be kept in an online database for a three year
period of time.
D. Personnel Hygiene
1. Employees working in the sterile products area must follow all gowning, garbing, and hand
hygiene requirements:
a. Personnel must remove personal outer garments and don a pair of freshly laundered
UWHC issued scrubs. If additional personal garments are worn they must not protrude
out from the scrubs unless covered by a compounding gown. All cosmetics, hand, wrist,
and other visible jewelry and piercings must be removed. No artificial nails or nail polish
is permitted and natural nails must be neat, clean, & trimmed.
b. Lab coats, scrub pants and shirts and low shedding gowns shall be picked up as needed
from the appropriate linen supply. They are not permitted to leave the hospital or to be
laundered at home.

POLICY & PROCEDURE





Effective Date:
Aug 2014
☒Pharmacy Policy Manual
☐Operations Procedure Manual


Policy: 6.0

☐Original
☒Revision 10/16

Page 3 of 6

Title: Sterile Product Preparation


2. All personnel compounding hazardous medications must don the proper personal protective
equipment before entering the compounding area. This includes all required sterile products area
garb as well as 2 pairs of nitrile gloves and chemotherapy spill resistant gown.
a. Chemotherapy gloves: Select powder free, high quality, sterile nitrile gloves that meet the
ASTM standard for chemotherapy gloves.
b. Compounding personnel must wear two pairs of gloves. Outer gloves must be
chemotherapy approved gloves.
c. Gloves should be changed every 30 minutes or when visibly contaminated or soiled.
3. Personnel who are afflicted with rashes, sunburn, weeping sores, conjunctivitis, and active upper
respiratory tract infections may be excluded from working in the critical or anteroom until their
condition is remedied, at the discretion of the pharmacist in charge. Staff may be reassigned to
other tasks outside of the compounding area by the employee’s supervisor or pharmacist in
charge.
E. Sterile Product Preparation
1. All preparation, reconstitution, and preparation documentation must adhere to the procedure as
defined by the Pharmacy Operations Manual.
2. All CSPs must be verified by a pharmacist according to the Pharmacy Operations Manual prior to
being released for patients.
3. For CSPs that contain narcotic substances, refer to Pharmacy Policy 7.15 Narcotic Control in the
Sterile Products Area for appropriate handling.
4. All hazardous medications will be prepared in a manner that minimizes the risks involved with
handling hazardous drugs and adheres to the appropriate procedure for compounding hazardous
drugs as outlined by the Pharmacy Operations Manual.
a. Negative-pressure, aseptic technique will be utilized when preparing hazardous drug
products. Volume of injections must be ≤75% of maximum syringe volume capacity to
prevent accidental spillage.
b. Only one hazardous drug should be prepared at a time in the BSC. If an item requires
time to dissolve, care must be taken to segregate it from any other product preparation.
c. All High-Risk hazardous medications will have the appropriate IV sets attached and
primed in the BSC.
i. High risk HD should be primed with base solution using a secondary IV line.
ii. All research medications being administered on D6/6 or CRU must be primed
with a primary IV line and will be primed with drug solution.
iii. Unless otherwise specified in clinical trial protocols, IV tubing will be primed
with base solution before the hazardous medication is added.
d. After preparation is complete, all materials must be wiped with USP approved cleaning
gauze to prevent additional exposure.
e. Disposable equipment and supplies used during hazardous drug preparation will be
destroyed per UWHC Administrative policy 5.27.
5. Hazardous spills and employee exposure should be handled according to hospital policy.
a. Hazardous medication spill kits will be located in each compounding area. Refer to
Hospital Policy 12.03 Hazardous Material and Waste Management Plan for specific
instructions to clean up spills.
b. Refer to Hospital Policy 8.89 Preventing Occupational Exposure to Hazardous drugs for
specific instruction on employee exposure to hazardous drugs.

POLICY & PROCEDURE





Effective Date:
Aug 2014
☒Pharmacy Policy Manual
☐Operations Procedure Manual


Policy: 6.0

☐Original
☒Revision 10/16

Page 4 of 6

Title: Sterile Product Preparation


6. Beyond-use date (BUD) and time
a. BUDs must be displayed on the product label in the following format: (time, day, month
and year – e.g. 1400 05 Jun 07).
b. BUDs are programmed into the pharmacy information system and will automatically
print on the product label or provide guidelines for the sterile compounding staff to write
on the product label (e.g., 48 hrs).
c. BUDs for investigational or research drugs will be established by the Pharmaceutical
Research Center (PRC) based on protocol stipulations and will be declared in the PRC
preparation instructions and corresponding labels.
d. Any large volume parenteral solution bags used for reconstitution must be newly opened,
labeled with a 6 hour BUD, and retained in the ISO Class 5 environment. All expired
bags must be discarded and no longer used for compounding.
e. Single dose vials (SDVs) containing no preservatives must be discarded at the end of
each day at the beginning of the third (night) shift. Partially used SDVs must be placed
in front of their respective bin to ensure daily discard.
f. Multiple dose vials (MDVs) containing preservatives are labeled to indicate a 28 day
discard date from initial puncture.
7. All CSPs must be appropriately labeled as follows
a. Patient's name (except for batch preparations)
b. Patient Location (e.g. Nursing unit/room number, Clinic, etc) (except stock preparations)
c. Base solution and volume (if appropriate)
d. Additives or drug with name, strength, and dose
e. Auxiliary labeling shall be included as appropriate.
f. Beyond-use date & time
g. Control number
h. Investigational drugs and/or research drugs labels will also reflect “For Investigational
Use Only” terminology (if applicable) and protocol identification. Research labels may
deviate from some of the elements noted above if required for blinding purposes or per
study protocol.
8. In addition to the labeling requirements outlined above, all hazardous CSPs must be dispensed in
an impervious zip-lock bag clearly labeled as “HAZARDOUS DRUG” and auxiliary labeling
addressing the following information must be affixed to the product:
a. Cautionary statement
b. Requirement of PPE
9. All intrathecal medications must be labeled with a purple “For intrathecal use only” label. This
label shall be placed over the top of the luer lock cap.
10. Vinca alkaloids must be prepared and labeled according to the Vinca Alkaloid Preparation
operating procedure.
F. Personnel Initial and Ongoing Training and Competency
1. The preparation of CSPs may be performed by either a pharmacist or pharmacy technician under
the supervision of a registered pharmacist.
2. All pharmacists who compound CSP’s or supervise the preparation of CSP’s and technicians who
prepare CSP’s must successfully pass all required initial training and competency assessments
prior to compounding or supervising the compounding of sterile products intended for patients.

POLICY & PROCEDURE





Effective Date:
Aug 2014
☒Pharmacy Policy Manual
☐Operations Procedure Manual


Policy: 6.0

☐Original
☒Revision 10/16

Page 5 of 6

Title: Sterile Product Preparation


a. Initial required training and competency assessments include didactic coursework,
practical skill assessments, media-fill challenge test and three separate gloved fingertip
samples.
b. After completion of all initial training, the clean room Technical Supervisor and clean
room Pharmacy Manager will verify all appropriate items have been initialed and dated
by trainee and trainer and that a competency assessment has been completed satisfactorily
for each area for which training has been completed.
c. Documentation of completed training, written and practical competency assessments will
be reviewed and initialed by Sterile Products Pharmacy Manager and filed in employee’s
personnel file.
3. All pharmacists who compound CSP’s or supervise the preparation of CSP’s and technicians who
prepare CSP’s must successfully pass all required ongoing training and competency assessments
at least once every 12 months as required.
a. Annual required training and competency assessments include didactic coursework,
practical skill assessments, media-fill challenge test and one random gloved fingertip
sample.
b. After completion of all annual competency assessments, the clean room Technical
Supervisor or clean room Pharmacy Manager will verify all appropriate items have been
completed satisfactorily.
c. Documentation of completed written and practical competency assessments will be
reviewed and initialed by the clean room Technical Supervisor or Sterile Products
Pharmacy Manager and filed in employee’s personnel file.
4. All personnel who compound sterile hazardous medications must successfully complete the
hazardous drug preparation training and all sterile products training prior to preparing
medications intended for patients.
5. Personnel who fail written or practical competency assessments, will be immediately reinstructed
and reevaluated according to the following steps to ensure competency in all aseptic processes:
a. Failure 1 - Consultation with the employee regarding the failed test to determine if
additional education is needed and repeat of testing.
b. Failure 2 – Additional education will be provided to the employee in the area leading to
the failed test and repeat of testing is required.
c. Failure 3 – Employee will complete the entire sterile products area training course and
repeat all initial testing is required.
d. Failure 4 – Employee will be removed from the sterile products area work environment
and will be trained in a different location. Employee will no longer be allowed to work in
the sterile products area.
e. Documentation of all remedial written and practical competency assessments will be
reviewed and initialed by Sterile Products Pharmacy Manager and filed in employee’s
personnel file.
III. REFERENCES
A. Pharmacy Policy 1.23 - Pharmacy Retention Records
B. Pharmacy Policy 4.1 - Medication Delivery via Pneumatic Tube System
C. Pharmacy Policy 7.15 - Narcotic Control in the Sterile Products Area

POLICY & PROCEDURE





Effective Date:
Aug 2014
☒Pharmacy Policy Manual
☐Operations Procedure Manual


Policy: 6.0

☐Original
☒Revision 10/16

Page 6 of 6

Title: Sterile Product Preparation


D. Pharmacy Policy 1.31 - Handling of Hazardous Drugs in Pharmacy
E. Hospital Policy 8.89 - Preventing Occupational Exposure to Hazardous Drugs
F. Hospital Policy 5.27 - Waste Management
G. Hospital Policy 12.03 - Hazardous Material and Waste Management Plan
H. ASHP Guidelines on Handling Hazardous Drugs. Am J Health-Syst Pharm 2006; 63:1172-93.
I. NIOSH Alert 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs
in the Health Care Setting.
J. Inpatient Pharmacy Operations Manual
IV. COORDINATION
A. Author: Pharmacy Manager, Sterile Products Area
B. Approved By: Pharmacy Operations Committee




Approved By: ____________________________
Director of Pharmacy Services

Date: ____________