training for aseptic processing...

www.pharmtech.com14 Pharmaceutical Technology ASEPTIC PROCESSING 2003

leanrooms all have one commonperformance criterion: to providean atmosphere that will protect theproduct from a hostile environ-

ment. Operators in cleanrooms must betrained in various disciplines, practices,and skills. Training must be a dynamicprocess to meet the job requirements andthe demands of contamination control.

RequirementsEvery employee must have the education,training, and experience to perform theassigned job functions. Three basic train-ing needs exist in today’s healthcare mar-ketplace: initial training, ongoing train-ing, and new skills training.

Initial training.Initial training is requiredfor all new employees. The goals must in-clude● a general understanding of good man-

ufacturing practices (GMPs)● a detailed explanation of the GMP regu-

lations that pertain to the job function,including the job’s application of theGMP principles

● written standard operating procedures(SOPs) specific to the job

● specific operations and handling re-quirements.Ongoing training (review). Ongoing train-

ing is a continuous awareness program,which can be held semiannually, quarterly,or monthly. Ongoing training is alsoknown as a refresher course. It should in-clude a short review of the basics with spe-cific emphasis on SOP review, gowning,aseptic techniques, compliance issues, andchanges in processing. Personnel shouldreceive training with sufficient frequencyto ensure that operations meet requiredspecifications.

New skills training. New skills training isjob-specific training for employees whowill be handling new equipment, using anew process, or changing positions. Thistraining is concurrent with a change in anSOP and/or a change control event. New-equipment training must involve exten-sive hands-on instruction in addition tothe classroom course.

Anne Marie Dixon is theowner and president ofCleanroom ManagementAssociates, Inc., 415 OldWashoe Circle, Carson City, NV89704, tel. 775.849.1313, fax. 775.849.1345, annemarie@cleanroommanagement.com

Training for Aseptic Processing EnvironmentsAnne Marie Dixon

ME

RC

K K

GaA

Training for asepticprocessing cleanroomsmust be a dynamic processto meet job requirementsand industry demands. Theauthor discusses variousapproaches that may betaken to ensure asuccessful training session.

C

Continued on page 40

40 Pharmaceutical Technology ASEPTIC PROCESSING 2003 www.pharmtech.com

Classroom training modulesBefore they are trained in specific skills,operators should receive a job descriptionas well as background information aboutthe company and its products. The clean-room classroom training can then be di-vided into segments or modules. Thesesegments should include● background information about clean-

rooms, rules, regulations, and person-nel issues. This segment gives the stu-dent the fundamentals on which to buildhis or her education.

● GMPs, product requirements, and over-all operational understanding

● gowning, aseptic techniques, work-station cleaning, and sanitization.

A higher training level would compriseadvanced courses for monitoring andother complex product-related issues.

Hands-on practiceStudents should have the opportunity tolearn, observe, and practice. Every level ofclassroom instruction should be followedby hands-on training. In my 27 years ofexperience in cleanroom training, I havenever met anyone who could perfect theart of donning a sterile garment by watch-ing a demonstration or a video. A videoor classroom demonstration can intro-duce the activity, but nothing can replacean actual practice session. After observa-tions and practice, a follow-up classroomsession is recommended to ensure that theconcepts learned are well understood,questions are answered, and retraining isperformed if necessary.

Simulating real conditionsProper instructin of today’s aseptic tech-niques require the use of a training labo-ratory or a real laboratory. Training in acleanroom would be a tremendous ad-vantage because operators and technicianscould practice aseptic techniques, envi-ronmental monitoring, sterility testing,cleaning and sanitization, equipment set-

up, and filling procedures under actualconditions.

If training in a cleanroom is not pos-sible, the use of a mock cleanroom willstill be beneficial. If an area is created tosimulate a gownroom, fill suite, or steril-ity lab, personnel an simulate productionactivity.

If a cleanroom or laminar-flow hood isavailable, hand fills could be done there.This would allow a person to have suffi-cient background in aseptic training be-fore production media–fill qualification.

Competency-based trainingThroughout the training process, em-ployees must know their job responsibil-ities and what is expected.Training pro-grams should be competency based; thatis, based on the knowledge and skills thateach employee must have to perform hisor her specific job function.

Documentation of training only ensuresthe training department of a person’s pres-ence in a course. It does not necessarilyverify the employee’s comprehension norability to perform the function. Therefore,verification of the employee’s ability to per-form the work required after training iscritical.

Testing, although necessary, is not a suf-ficient verification method and will notqualify employees on for assigned func-tions. Many companies are especially re-luctant to test senior employees. However,human resource departments are con-cerned about the employee who has beenin a position for many years and who thenfails written tests.

Certification also should be part of atraining program. The certification processinvolves demonstration of a defined taskusing a predetermined checklist by an au-thorized observer. Objectives of any train-ing program must be defined and the out-come assessment understood beforespecific training is implemented. In manycases, this may require an assessment ofthe current situation and an understand-ing of the desired objectives. It must bemade clear whether the training sessionmust be conducted as an initial trainingcourse or as a retraining course becauseof a problem or other reason.

The five “I’s” of trainingInspire. Management must inspire em-

ployees to improve their performance.Some people have a built-in need to per-form and achieve and have a motivatedpersonality. Other people work hard toimprove and earn a chance for advance-ment. However, certain individuals mayneed the participation and involvementof management to become motivated.

Identify. Identifying a performance im-provement helps inspire employees. Apoor performance can identify a need fortraining.

Inform. Information is the training ortransfer of skills and experiences.

Implement. Implementation is the re-sult of proper training.

Institutionalize. Institutionalizing is themaintaining of the skill level of the oper-ator work force and is the responsibiity ofmanagement.

Management’s roleCommitment is key in aseptic training,and the role of management is critical.Management must participate in moti-vating the work force while investing intraining programs, staff, equipment, andtime. Remember, “If you think educationis expensive, try ignorance.” Because asep-tic processing is a high-risk operation, acontinuous awareness program must beestablished.

Management also must support propersupervision. Nonperformance or short-cuts are not acceptable. Proper cleanroomprotocols, aseptic techniques, and follow-ing SOPs are all part of expected and de-sired employee performance. PT

● Inspire● Identify● Inform

● Implement● Institutionalize

The five “I’s” of training

Continued from page 14