Cleanroom Training Checklist - PDF by fco12696

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									            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. P    T
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

								
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