Application Note – Cleanroom N.03
Education of staff in Cleanroom
We report the Chapter “Personnel” on pages 7 and 8 of the Annex I of the Eudralex document “The rules governing medicinal products in the European Union” 25 November 2008 (rev.)
36. Only the minimum number of personnel required should be present in clean areas; this is particularly important during aseptic processing. Inspections and controls should be conducted outside the clean areas as far as possible.
37. All personnel (including those concerned with cleaning and maintenance) employed in such area should receive regular training in disciplines relevant to the correct manufacture of sterile products. This training should include reference to hygiene and to the basic elements of microbiology. When outside staff who have not received such training (e.g.: building or maintenance contractors) need to be brought in, particular care should be taken over their instruction and supervision.
38. Staff who have been engaged in the processing of animal tissue material or of cultures of microorganisms other than those used in the current manufacturing process should not enter sterile products areas unless rigorous and clearly defined entry procedures have been followed.
39. High standards of personnel hygiene and cleanliness are essential. Personnel involved in the manufacture of sterile preparation should be instructed to report any condition which may cause the shedding of abnormal numbers or types of contaminants; periodic health checks for such conditions are desirable. Actions to be taken about personnel who could be introducing undue microbiological hazards should be decided by a designated competent person.
40. Wristwatches, make-up, and jewellery should not be worn in clean areas.
41. Changing and washing should follow a written procedure designed to minimize contamination of clean area clothing or carry-through of contaminants to the clean areas.
42. The clothing and its quality should be appropriate for the process and the grade of the working area. It should be worn in such a way as to protect the product from contamination.
43. The description of clothing required for each grade is given below:
Hair and, when relevant, beard should be covered. A general protective suit and appropriate shoes or overshoes should be worn. Appropriate measures should be taken to avoid any contamination coming from outside the clean area.
Hair and where relevant beard and moustache should be covered. A single or two-pieces trouser suit, gathered at the wrist and with high neck and appropriate shoes or overshoes should be worn. They should shed virtually no fibres or particulate mater.
Headgear should totally enclosed hair and, where relevant, beard and moustache; it should be tucked into the neck of the suit; a face mask should be worn to prevent the shedding of droplets. Appropriate sterilized, non-powdered rubber or plastic gloves and sterilized or disinfected footwear should be worn.
Trouser-legs should be tucked inside the footwear and garment sleeves into the gloves. The protective clothing should shed virtually no fibres or particulate matter and retain particles shed by the body.
44. Outdoor clothing should not be brought into changing rooms leading to Grade B and C rooms. For every worker in Grade A/B area, clean sterile (sterilized or adequately sanitized) protective garments should be provided at each work session. Gloves should be regularly disinfected during operations. Masks and gloves should be changed at least for every working session.
45. Clean area clothing should be cleaned an handled in such a way that it does not gather additional contaminants which can later be shed. These operations should follow written procedures. Separate laundry facilities for such clothing are desirable. Inappropriate treatment of clothing will damage fibres and may increase the risk of shedding of particles.