Training for Aseptic

Processing Environments
Anne Marie Dixon

Training for aseptic

processing cleanrooms
must be a dynamic process
to meet job requirements
and industry demands. The
author discusses various
approaches that may be
taken to ensure a

MERCK KGaA
successful training session.

C
leanrooms all have one common ● written standard operating procedures
performance criterion: to provide (SOPs) specific to the job
an atmosphere that will protect the ● specific operations and handling re-

product from a hostile environ- quirements.

ment. Operators in cleanrooms must be Ongoing training (review). Ongoing train-
trained in various disciplines, practices, ing is a continuous awareness program,
and skills. Training must be a dynamic which can be held semiannually, quarterly,
process to meet the job requirements and or monthly. Ongoing training is also
the demands of contamination control. known as a refresher course. It should in-
clude a short review of the basics with spe-
Requirements cific emphasis on SOP review, gowning,
Every employee must have the education, aseptic techniques, compliance issues, and
training, and experience to perform the changes in processing. Personnel should
assigned job functions. Three basic train- receive training with sufficient frequency
ing needs exist in today’s healthcare mar- to ensure that operations meet required
ketplace: initial training, ongoing train- specifications.
ing, and new skills training. New skills training. New skills training is
Initial training. Initial training is required job-specific training for employees who
Anne Marie Dixon is the for all new employees. The goals must in- will be handling new equipment, using a
owner and president of
Cleanroom Management
clude new process, or changing positions. This
Associates, Inc., 415 Old ● a general understanding of good man- training is concurrent with a change in an
Washoe Circle, Carson City, NV ufacturing practices (GMPs) SOP and/or a change control event. New-
89704, tel. 775.849.1313, ● a detailed explanation of the GMP regu- equipment training must involve exten-
fax. 775.849.1345, annemarie@ lations that pertain to the job function, sive hands-on instruction in addition to
cleanroommanagement.com
including the job’s application of the the classroom course.
GMP principles Continued on page 40
14 Pharmaceutical Technology ASEPTIC PROCESSING 2003 www.phar mtech.com
Continued from page 14 up, and filling procedures under actual ployees to improve their performance.
conditions. Some people have a built-in need to per-
Classroom training modules If training in a cleanroom is not pos- form and achieve and have a motivated
Before they are trained in specific skills, sible, the use of a mock cleanroom will personality. Other people work hard to
operators should receive a job description still be beneficial. If an area is created to improve and earn a chance for advance-
as well as background information about simulate a gownroom, fill suite, or steril- ment. However, certain individuals may
the company and its products. The clean- ity lab, personnel an simulate production need the participation and involvement
room classroom training can then be di- activity. of management to become motivated.
vided into segments or modules. These If a cleanroom or laminar-flow hood is Identify. Identifying a performance im-
segments should include available, hand fills could be done there. provement helps inspire employees. A
● background information about clean- This would allow a person to have suffi- poor performance can identify a need for
rooms, rules, regulations, and person- cient background in aseptic training be- training.
nel issues. This segment gives the stu- fore production media–fill qualification. Inform. Information is the training or
dent the fundamentals on which to build transfer of skills and experiences.
his or her education. Competency-based training Implement. Implementation is the re-
● GMPs, product requirements, and over- Throughout the training process, em- sult of proper training.
all operational understanding ployees must know their job responsibil- Institutionalize. Institutionalizing is the
● gowning, aseptic techniques, work- ities and what is expected.Training pro- maintaining of the skill level of the oper-
station cleaning, and sanitization. grams should be competency based; that ator work force and is the responsibiity of
A higher training level would comprise is, based on the knowledge and skills that management.
advanced courses for monitoring and each employee must have to perform his
other complex product-related issues. or her specific job function. Management’s role
Documentation of training only ensures Commitment is key in aseptic training,
the training department of a person’s pres- and the role of management is critical.
The five “I’s” of training ence in a course. It does not necessarily Management must participate in moti-
● Inspire ● Implement verify the employee’s comprehension nor vating the work force while investing in
● Identify ● Institutionalize ability to perform the function. Therefore, training programs, staff, equipment, and
● Inform verification of the employee’s ability to per- time. Remember, “If you think education
form the work required after training is is expensive, try ignorance.” Because asep-
critical. tic processing is a high-risk operation, a
Hands-on practice Testing, although necessary, is not a suf- continuous awareness program must be
Students should have the opportunity to ficient verification method and will not established.
learn, observe, and practice. Every level of qualify employees on for assigned func- Management also must support proper
classroom instruction should be followed tions. Many companies are especially re- supervision. Nonperformance or short-
by hands-on training. In my 27 years of luctant to test senior employees. However, cuts are not acceptable. Proper cleanroom
experience in cleanroom training, I have human resource departments are con- protocols, aseptic techniques, and follow-
never met anyone who could perfect the cerned about the employee who has been ing SOPs are all part of expected and de-
art of donning a sterile garment by watch- in a position for many years and who then sired employee performance. PT
ing a demonstration or a video. A video fails written tests.
or classroom demonstration can intro- Certification also should be part of a
duce the activity, but nothing can replace training program. The certification process
an actual practice session. After observa- involves demonstration of a defined task
tions and practice, a follow-up classroom using a predetermined checklist by an au-
session is recommended to ensure that the thorized observer. Objectives of any train-
concepts learned are well understood, ing program must be defined and the out-
questions are answered, and retraining is come assessment understood before
performed if necessary. specific training is implemented. In many
cases, this may require an assessment of
Simulating real conditions the current situation and an understand-
Proper instructin of today’s aseptic tech- ing of the desired objectives. It must be
niques require the use of a training labo- made clear whether the training session
ratory or a real laboratory. Training in a must be conducted as an initial training
cleanroom would be a tremendous ad- course or as a retraining course because
vantage because operators and technicians of a problem or other reason.
could practice aseptic techniques, envi-
ronmental monitoring, sterility testing, The five “I’s” of training
cleaning and sanitization, equipment set- Inspire. Management must inspire em-
40 Pharmaceutical Technology ASEPTIC PROCESSING 2003 www.phar mtech.com