| Using
Equipment and Products to Successfully
Meet
USP Chapter <797> Standards
Submitted
by Eric
Kastango, RPh, MBA, FASHP of Clinical
IQ (www.clinicaliq.com)
THE
RECENTLY PUBLISHED USP CHAPTER <797>, PHARMACEUTICAL
Compounding: Sterile
Preparations, became effective January 1, 2004. This General
Tests and Assays chapter details the procedures andrequirements
for compounding sterile preparations and sets standards that
are applicable to all practice settings inwhich sterile preparations
are com-pounded. These standards are now enforceable by state
boards of pharmacy and surveyable by accreditation organizations(JCAHO,
ACHC and CHAP). It is important to realize that USP/NF
standards havebeen successfully upheld in lawsuits as national
standards of practice that take precedence over individual
state board of pharmacy practice acts. The following
will provide administrators, pharmacists, and technicians
with information on equipment and products to achieve compliance
with these new sterile preparation compounding standards.
Though not all of the 12 to 14 quality domains within USP
Chapter <797> will be addressed by equipment or products,
those that can be addressed with equipment and products are
outlined below:
Quality
Assurance Program
This quality domain
details the need for written policy and procedures and personnel
job descriptions. Policy and procedures are important forthe
following reasons:
- They are critical to properly
training employees
- They clearly define an organization’s
expectations, rules, and regulations
- They ensure that everyone
is performing a function in the same manner
- They can be used to document
that a certain function or activity was performedMost, if
not all, policy and procedure software will need to be cus-tomized
to match the actual practices that occur in the pharmacy.
This activity can
be the most time-consuming of the all the actions that haveto
be taken to meet the quality requirements of USP Chapter <797>.
When purchasing a policy and procedure manual, ensure that
it can be electronically modified (in Microsoft®Word or
Word Perfect®) so as to reflect organizational practices
and ongoing changes. Software should include templates that
can be used to prepare new policies that may not be included
in the original set. A number of vendors provide software
that can be customized to meet the specific operating procedures
of the pharmacy. These include:
Quality
Assurance Practices
This quality domain
details the need for specific quality practices that canensure
the purity, potency, and sterility of the compounded sterile
preparation. When compounding sterile preparations from bulk,
nonsterile, powders, it is important to use an electronic
scale to accurately weigh the ingredients. Many states require
scales to be NTEP approved. The National Type Evaluation Program
(NTEP) performs evaluations of weighing and measuring devices
for compliance with National Institute Standards and Technology
Office of Weights and Measures(NIST) Handbook. A NTEP scale
is a quality precision weighing balance that has undergone
independent testing to verify the unit meets the manufacturer’s
specifications. The scale should have a RS232C interface which
allows a connection to aprinter or PC. Adding a printer to
a scale or printing to a computer file provides additional
quality documentation of weighed ingredients. NTEP scales
are available from the following manufacturers:
Another important
QA practice involves adequate employee training and validation
of employee competency relative to the principles of contami-nation
control and aseptic technique. A CD-ROM published by The American
Society of Health-Systems Pharmacists, “Sterile Product
Preparation—A Multimedia Learning Tool,” is a
computer-based, interactive learning program that provides
a thorough way to train pharmacists, technicians, and students.
The software features virtual preparation andclean rooms,
unique user IDs, self-assessment exams, a mouse-over glossary,
photos and video clips. This comprehensive network-based program
comes with 10 “user seats”. The results of each
chapter’s learning assessment quizzes can be printed
and filed into the employee’s personnel fileas evidence
of training. The program also provides 5.0 CEU per user at
no additional cost. The CD can be purchased in the software
products section of ASHP’s website(www.ashp.org).
In addition to providing didactic train-ing, it is crucial
to validate the aseptic technique of each employee who compounds
sterile preparations. Proper
aseptic technique is an acquired skill. Pharmacists and technicians
who compound must complete aseptic technique validation before
they are allowed to produce CSPs. Aseptic
technique validation is accomplished by means of media fills,
in which actual compounding conditions and aseptic processes
are simulated to demonstrate that microorganisms are not introduced
during process-related activities. The activities performed
by the operator during the media fill should mimic actual
compounding activities as closely as possible, because those
activities are the source of the greatest risk of contamination.
Several aseptic technique validation kits are currently available.
Vendors include:
Environmental
Control and Monitoring Program
Establishing a comprehensive
and robust environmental monitoring (EM) program will provide
information on elements of a sterile com-pounding operation.
An EM program can:
- Identify trends and address issues before they become
critical. For example, environmental air and surface sampling
can identify shifts in microbial bioburden that will stimulate
assessment of potential points of failure such as improper
employee gowning and gloving, improper cleaning procedures
related to changes in maintenance personnel, or problems
with HEPA filtration units.
- Facilitate a reflective process whereby an evidence-based
assessment of potential points of failure can be identified
so that processes can be modified, and potential failures
prevented from occurring.
Air and surface
sampling involve collecting environmental “snapshots”on
Tryptic soy broth (TSB)/agar (TSA) plates that support the
growth of many types of microorganisms. Air sampling is accomplished
by placing air-settling plates or paddles at various locations
throughout the con-trolled environment according to the types
of activities performed or the number of personnel and product
movement in the area. “Settling plates” are TSA
agar plates that are 100 mm in diameter. They should be exposed
to cleanroom air for a period of at least 1 hour but not more
than 3 hours. Air sampling is a cost-effective way of obtaining
quantitative data relative to the viable microbial particles
expected to settle from the air at each sampling site. Surface
sampling can be performed with raised TSA platesthat are 60
mm in diameter (rodac plates) or paddles. The TSA in rodac
plates is mixed with polysorbate 80 and lecithin, which in
activates many residual disinfectants. Polysorbate 80 neutralizes
phenols, hexachlorophene, and formalin, and lecithin inactivates
quater-nary ammonium compounds. During sampling, a rodac plate
is pressed onto the area to be tested. Any microorganisms
on the surface of the area tested (which should ideally be
flat) are transferred onto the rodac plate. The collection
plates are covered and incubated at 30°– 35°C
(86°– 95°F) in an incubator for 48–72
hours. After the incubation time, the plates are inspected
and any discrete colonies, known as colony forming units (CFUs)
that grow on the plates are counted at the completion of the
incubation period and are noted on a collection form. Sources
of these environmental sampling plates, swabs and paddles
include:
Incubators are needed
to createtemperature control environmentsof exacting specification.
The mostcommon temperature used toincubate environmental or
com-pounded sterile preparation qual-ity assurance samples
is 25°–35°C. Tabletop incubators areavailable
from a number of ven-dors, including:
Summary
Ensuring the sterility
and accuracy of compounded sterile preparations is the principal
object of USP Chapter <797>. Pharmacists and technicians
play a crucial role in the quality of CSPs. Having the proper
equipment and supplies will support this role and compliance
with the requirements of USP Chapter <797>. In addition
to the vendors mentioned in this article, there are several
others who offersimilar products. It is important to research
the vendors who provide equipment and products as solutions
to USPChapter <797> needs. Find out what you need to
know by reading theUSP Chapter, which can be purchased from
USP (www.usp.org).
After reading USP <797>, you will be armed with the
information you need toseparate hearsay from fact when deciding
on the right equipment and supplies to deliver a quality compounded
sterile preparation.
Eric
Kastango,RPh,MBA,FASHP operates his consulting company, Clinical
IQ, out of Florham Park,New Jersey.He provides expertise in
the area of aseptic process-ing (pharmacy and pharmaceutical
based),medical device manufacturing,and the implementation
of extemporaneous compounding quality systemsfor a variety
of clients.He is also pharmacy surveyor for the AccreditationCommission
for Health Care,Inc.(ACHC). |
|
Millipore
Swab Test
Kit
and Samplers
|
