Newsletter_07-2024_EN

In particular, many companies, switching to under-isolator
production, are considering the use of concentrated products for
Grade C/D outdoor environments. Would you recommend their
use? If so, with which procedure?
Yes, there are no concerns, especially within lower grades of cleanrooms.
The important point is to ensure the dilution is correct and
that the correct grade of water is used.
Training of personnel
Personnel training: with the latest Annex 1, and the increasingly
stringent rules on cleaning and disinfection, personnel training is
a key point. Are there also changes in training methods with the
new Annex 1?
The Annex could go further with training. Appropriate training for all
personnel dealing with disinfectants is vital. This training should include
all relevant staff including contract personnel working within
the facility. Documentation of this training is essential. All personnel
should understand the importance of cGMP. For a new employee,
this training could be part of their initial GMP induction. A pre-determined
program of training should be in place and documented as
well as a system to measure the effectiveness of the training. Personnel
should all be trained in good cleaning techniques using the appropriate
equipment. All staff should be provided with appropriate
clothing in order to perform this operation, e.g., cleanroom clothing
in manufacturing areas with adequate PPE. Procedures should also
be in place if spillage occurs with any of these agents.
Training programs could include:
– The importance of disinfection in relation to GMP, its necessity
in preventing microbial proliferation, cross contamination and
the importance and significance of good disinfection routines.
– The importance of the correct handling of disinfectants, whether
it is during the disinfectant’s preparation, testing or use.
– Basic microbiology and how contamination is transferred in the
workplace.
– An understanding of the properties of disinfectants and their
correct application.
A refresher program should also be in place, ensuring that once personnel
are trained, their knowledge is kept up to date. Many companies
now incorporate this into regular GMP refresher training,
recommended to be undertaken on a periodic basis. Adequate documentation
of these updates in an employee training record is essential.
Cleaning & Disinfection in Grade C & D areas
Finally, the CCS in the new Annex 1 extends to all areas at risk of
contamination.
Also in paragraph 4.35 it is stated that “disinfectants used in grade
C and D may also be required to be sterile where determined in the
CCS”. This implies increased attention also for non-sterile areas
and for producers of cosmetics, ointments and biological intermediates
with low bacterial load etc. For the latter, the challenge will
certainly be significant. What are the essential activities to adapt?
Some good practices for the adoption and use of disinfectants, in
accordance with GMP, are:
– Written procedures should be in place.
– Responsibilities for cleaning should be assigned. Often this is interpreted
as the need to have independent cleaning staff separate
from those involved in product manufacture.
– Staff must be trained in cleaning techniques and have a training
record.
– Details of cleaning frequencies, methods, equipment, and
materials must be recorded in written procedures. This may
relate to an approved supplier specification.
– The cleaning of equipment and materials must take place
at regular intervals.
– Inspection of equipment for cleanliness before use should
be part of routine operations.
– A cleaning log should be kept. The purpose is to keep a record of
the areas cleaned, agents used, and the identity of the operator.
– The microorganisms isolated (the microbiota) from environmental
monitoring programs should be examined for resistant strains.
Some isolates from these reviews should be incorporated into
disinfectant efficacy studies.
– The monitoring for microbial contamination in disinfectant and
detergent solutions should be periodically undertaken.
– The storing of disinfectant and detergent solutions should be for
defined (and short) periods.
– Room use should be recorded after each operation.
– There should be a technical agreement with the company who
supplies the disinfectant. Ideally the disinfectants purchased
should be lot tracked.
– SOPs containing references to disinfectants, cleaning agents,
materials and equipment used and calibration of equipment
are accessible. Here the cleaning and disinfection methods are
clearly defined.
– The SOP should include cleaning method details e.g., wiping
front to back or top to bottom with overlapping strokes.
– Cleaning method, e.g., double bucket, rinsing wipe action, contact
time and cleaning of cleaning materials must also be included in
the
– Documentation of rotation, rationale, and frequency,
needs to be set out.
– Cleaning logs also need to be in place and available.
In compliance with GMP, cleaning and disinfection procedures
should be included in any audit program as it maintains assurance
that contamination control procedures are adequate and in control.
Conclusions
The Contamination Control Strategy underlying the new Annex 1
finds its backbone in Quality Risk Management: assessing risks on a
scientific basis and offering a commensurate response to them is the
real key to adapting to the new requirements.
Dr. Tim Sandle is a pharmaceutical microbiologist, science writer and
journalist. He is a chartered biologist and holds a first class honours
degree in Applied Biology; a Masters degree in education; and has a
doctorate from Keele University.
AM INSTRUMENTS
Via Isonzo, 1/C
Phone: +39 02 8728421
email: info@aminstruments.com
IT20812 Limbiate (MB)
Internet: https://global.aminstruments.com/
www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 07-2024
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