Personnel Qualification in Aseptic Areas

The assurance of the consistency, accuracy of the process is evolved through the process of the validation, Hence the validation plays a vital role to have the assurance over the process.
In general during the qualification process, the process or the elements of the process are challenged with the stringent conditions and the satisfactory output of the same is ensured. The scenario is simple as far as the qualification of the equipment is concern, wherein the equipment is challenged with the test parameters and comparison of the expected output over the actual output is compared.

Qualifying the person for working in aseptic areas

The situation is not simpler, when is comes to the personnel qualification, where the testing by applying the stringent condition as that of the equipment is not applicable. The other very important parameter is the behavior, hygienic practices, attitude and sensitiveness of the person varies from person to person and it is non measurable and still it is very important, especially , when you are in sterile facility.
In this article we will be looking at the qualification of the personnel for working in the manufacturing facility ( Especially sterile products) and documents to be established while doing the activity to have the evidence and justification for allowing personnel to work in that particular locations.

Selection, training, qualification and certification of the employee for activities

The very first pre–requisite as far as the working of the personnel goes, he/ she ( The word “ He” shall be considered as “He” or “she” in the article further) should be educationally enough qualified to do that particular job. Of course the candidates having experience and expertise in the area are preferred.
As far as the health and hygiene of the employee is concerned, the candidate seeking the job shall be medically tested for the contagious diseases, vision and listening abilities. The person having the contagious disease can be asked for seeking the medical treatment and joining after the treatment.
The person having less vision is not fit or the activities like visual inspection of goods or packing line for online checking of the artwork. Hence choose appropriate area for the person having less vision. The person having less ability to listen but good in vision can be employed for the visual inspection of goods.
In brief, choose the appropriate function of the activity, depending on the candidates physical status.
Pre employment training
The selected candidate shall be trained for the entry and exit procedure and the gowning procedure as applicable for the employee. The candidate shall also be trained for the general hygiene practices. The documented evidence of the training shall be created by the question and answer session, the candidate seeking less marks shall be retrained. Till satisfactory retraining the candidate shall not be considered for that particular activity.
After general health and hygiene training the candidate is given the job specific training.
Qualifying the person for the activities:
The class room training and the on job training shall be imparted to the employees involved in different activities. The classroom training and the on job training shall be followed by the evaluation of the employees for which the documented evidence is required.
The electronic audio visual recording may also be done to have the evidence of the training and the assessment.
The following session discusses the qualification of the employee for working in the visual inspection and the classified manufacturing locations (Aseptic areas).
Qualifying the person for the Working in aseptic areas
The personnel trained for the hygienic practices shall be considered for the working in the critical areas. The employee shall be qualified by undergoing following training and activities successfully. Following are the training/ activities which shall be performed sequentially to the employee.
Classroom training on the behavior in the aseptic areas
The classroom training on the behavior in the aseptic areas shall be imparted to the employee, in which the employee is trained for the behavior and precautions to be taken, while working in the aseptic areas. The question answer session shall be followed after the training.
Classroom training for the gowning
During this session the employee shall be trained for the gowning practices and related SOP’s like: Ornament policy for the aseptic areas, Entry and exit procedures for the areas of the different classifications, gowning procedure.The employee shall be evaluated for training on each SOP by the question and answer session after the training.
On job training for the gowning
The on job training on the gowning procedure is imparted to the employee in which the employee shall be trained physically to perform the gowning. The electronic recording of the same may be performed to have the evidence on the training session.
Qualification of the employee for the gowning
The trained employee shall be allowed to enter in the aseptic areas and the surface counts on the fingers tips, armpits, buttocks, forearms etc shall be taken on the gown. The surface counts shall not exceed beyond the set acceptance criteria ,normally considered as < 5 or < 1 depending on the location. This activity shall be performed for three consecutive days. If the employee has the count of less than pre defined acceptance criteria for all three days and all locations , then the employee shall considered to be qualified for gowning.
The list of the employee shall be prepared and it shall be authorized by the Head QA, these people shall be allowed to work in the aseptic areas (not actual filling location). i.e the employee can work in support area like manufacturing of bulk.
Qualification of employee who enter in the filling suit at the time of batch manufacturing
The employee who passed in the gowning qualification shall only be qualified for entering in the filling locations. The employee which are selected for the filling location shall participate in media fill activity during filling.
These employees includes, Operators of filling machine, Supervisors of filling machines, Microbiologist performing the environmental monitoring and sampling during filling.
During media fill activity the employee shall perform the activity, which he is intended to perform during regular batch filling activity. After successful completion of the media fill activity, the employee shall be considered to be qualified for participation in batch manufacturing process.
Routine qualification of the employee
The routine qualification/ training of the employee shall be performed for all above training on fixed periodical intervals.Qualifying the person for the visual inspection activity.
Classroom and On Job training and evaluation
The employee having good vision shall be selected for the visual inspection activity. Once selected for the visual inspection activity, the employee shall be given the classroom for visual inspection activity is given. The written question answer session shall be followed after the classroom training.
The candidate is evaluated after the written test, If the candidate is not found to be upto the mark, the candidate is retrained, till satisfactory performance.
After satisfactory completion of the classroom training, the on job qualification of the employee shall be done in which employee is qualified for the visual inspection activity by doing on job training and evaluation.
During this activity the kit for the visual inspection shall be prepared in which the selected number of defective pieces shall be added and the ability of the candidate for sorting out the defective pieces shall be checked. After passing in the acceptance criteria the candidate is put on the job for the visual inspection.
Routine qualification of the employee for visual inspection activity
The eye checkup for the person qualified for the visual inspection activity shall be performed on the fixed time intervals; normally the eye checkup for these employees shall be done once in six months. The re-qualification for the visual inspection operators by using the visual inspection kit shall be performed at fixed intervals normally, once in a year.
Certification / Recertification of the employee
After completion of the all above mentioned activities or training, the certificate for each employee is prepared, which mentions the training imparted and qualification performed on the employee. The certificate certifies that the employee is certified to perform the intended activity. The due date of the recertification is mentioned on the certificate. The certificate shall be signed by the department head and the Head, QA after reviewing his training record. The above activities shall be performed on routine frequency for each qualified employee.
The employee shall be recertified after fixed time interval after completion of the all above training/ qualification on routine frequency.