11.

D Sanitation programme
Up07 Dr. Christian Gausepohl, Paolomi Mukherji

Here you will find answers to the following questions:

● What is a sanitation programme?

● What does a cleaning instruction for rooms consist of?

The requirement for a written sanitation programme is made in the EU-GMP-Guide (see Chapter C EU Directives and
Guidelines) and in 21 CFR Sec. 211.56 Sanitation. The sanitation programme defines all necessary plant hygiene
measures. In addition to personnel sanitation programmes (including clothing requirements, zonal behaviour, general
code of conduct, personal hygiene, etc.), the specific assignment of the individual rooms in the plant to the defined
cleanliness grades is also part of the sanitation programme. It is completed by schedules for cleaning and disinfection.

11.D.1 Organisation of room cleaning

The organization of room cleaning encompasses the following aspects:

● Hygienic areas
● General room cleaning
● Cleansing agents and disinfectants
● Cleaning process
11.D.1.1 Hygienic areas

All rooms of the plant have to be assigned to the respective hygienic areas (cleanliness grades). This involves the
definition of requirements and limits for the environmental monitoring (see Chapter D.7 and Chapter D.7).

It should be specified for each cleanliness grade, which surfaces (ceilings, walls, floors, benches) have to be cleaned
and/or sanitized in what intervals. The application method (wiping, spraying) has to be mentioned.

An example for this is given in Figure 11.D-1. The concrete definition of measures and frequencies depends on the
monitoring results.

Figure 11.D-1 Definition of cleaning and disinfection measures for different cleanliness
grades

cleanliness grade

Area/surface A,B (ISO 5) C (ISO 7) D (ISO 8) E

Ceilings C/D: daily to weekly C/D: weekly C: weekly C: weekly

D: monthly D: monthly

wipe wipe wipe wipe

Walls C/D: daily to weekly C/D: weekly C: weekly C: weekly

D: monthly D: monthly

wipe or spray wipe or spray wipe wipe

Floors C/D: daily C/D: daily C/D: daily C: daily

D: weekly

wipe wipe wipe wipe

critical benches C/D: daily C/D: daily C/D: daily C: daily

D: daily to weekly

wipe and spray wipe and spray wipe and spray wipe and spray
C: cleaning, D: disinfection

11.D.1.2 General room cleaning

This instruction lists all individual rooms of the plant. The responsibilities for cleaning and disinfection measures and for
the required execution intervals are listed. Groups of cleansing agents and disinfectants are assigned with the
corresponding aids for application. The necessary change of disinfectants is established (see Figure 11.D-2).

Figure 11.D-2 Overview of room cleaning

Location
A001 A002 A003 A004 A005 A006 A007 A008 A009 A010

Procedure Disinfection as req. X X X X X X X X X X

yr. _ _ _ _ _ _ _ _ _ _

mthly: _ _ _ _ _ _ _ _ _ _

wkly: _ _ X _ _ _ _ _ X _

dly: X X _ X _ _ _ X _ _

Cleaning as req. X X X X X X X X X X

yr. _ _ _ _ X _ _ _ _ _

mthly: _ _ _ _ _ X _ _ _ X

wkly: _ _ X _ _ _ X _ X _

dly: X X _ X _ _ _ X _ _

Medium Cleaning and disinf. F _ _ _ _ _ _ _ _ _ _

code
E _ _ _ _ _ _ _ _ X _

D _ X _ _ _ X _ _ _ _

C _ _ _ _ _ _ _ X _ _

B _ _ X _ _ _ _ _ _ _

A X _ _ X _ _ _ _ _ X

Aids 6 _ _ _ _ _ _ X _ _ _

5 _ _ _ _ X _ _ _ _ _

4 _ _ X _ _ _ _ _ _ _

3 X X - X _ _ _ _ _ _

2 _ X _ _ _ _ _ _ _ _

1 _ _ _ _ X X _ _ _ _

Responsibility Cleaning _ _ _ _ X X _ _ X X
group

Product group X X X X _ _ X X _ _

11.D.1.3 Cleansing agents and disinfectants

This section of the sanitation programme is where the different permissible cleansing agents and disinfectants are
named. They are coded in groups, e.g. by application or by physical-chemical characteristics (see Figure 11.D-3). This
enables a simple connection to general room cleaning and a simple replacement of agents, e.g. in case of changes.
These instructions should also specify the necessary concentration and acting times of the respective agents, in order to
enable proper application. In addition to separate systems, combined agents for cleaning and disinfecting are also
available on the market.

Figure 11.D-3 Grouping of cleansing agents and disinfectants

(Example)

Cleansing agent and disinfectant code

A B C D E F

Cleanfix AS X _ X _ _ _

Cleanfix AF X _ _ _ _ _

Superclean S X _ X _ _ _

Superclean V _ X _ _ _ _

Desinform X _ X _ _ _ _

Desi-Sept NA _ _ _ X _ _

Antisept Super _ _ _ X _ _

DS 45 _ _ _ _ X _

Anti-Micro 3 _ _ _ _ _ X

Compatibility with the material is very important. It is expected that the cleansing agents used will not cause any
interaction with the surfaces, i.e. will not bond with later release, and will not cause any modification of the surface
structures. This must be taken into account above all if different materials are processed in one room (e.g. floor tiles,
walls). For example, if aluminium surfaces are cleaned with acid cleaners (e.g. citric acid), the roughness is increased.

For production and filling rooms in aseptic or clean room areas, disinfection with formaldehyde can be carried out
depending on the technical circumstances. With an acting time of 6 to 16 hours, overnight disinfection is practical.
Various agents are available for disinfecting tables, floors, walls and drains (alcohols, aldehydes, quaternary ammonium
compounds or phenols).

When selecting the cleansing agent or disinfectant, it is also of importance to include the criterion of the tolerability of
the agent for the employee.

11.D.1.4 Cleaning process and aids

This section of the sanitation programme lists the different aids. The code grouping is used for classification in the
procedure for room cleaning (see Figure 11.D-4).

Figure 11.D-4 Grouping of the aids

(Example)

Aid code 1 2 3 4 5 6

Floor cloth X _ _ _ _ _

Mop X _ _ _ _ _
Brushes X _ _ _ _ _

Rubber squeegees _ X _ _ X _

Spray guns _ X X _ _ _

Low pressure foam device _ _ _ X _ _

Dry aspirator X _ _ _ _ _

Scrub suction device _ _ _ _ _ X

Water aspirator _ _ X X X _

The method of execution is important for the cleaning and disinfection result. Therefore the application, dispensing and,
if necessary removal of the cleansing agent or disinfectant solutions must be fixed in writing as well as the
concentrations used. In doing so, the experiences of the employees and the results from the monitoring should be
consolidated. Simply wiping the floor with a mop is sometimes not sufficient.

This simply redistributes the dirt, and mixes it with disinfectant. As an alternative, the floor can be flooded with
subsequent aspiration. Automatic floor cleaning machines are another alternative for large area applications (e.g.
corridors). In order to prevent transporting dust across the entire working area, it must be ensured that the aspirated
dust is not blown out again.

Cleaning is carried out in steps: application of the cleansing solution, floor wiping, and aspiration of the dirt solution;
rinsing may also be included. Depending on the location, it should ideally be possible to qualify such machines and thus
enable reproducible cleaning. The procedure must be matched to the individual circumstances.

11.D.2 Documentation
Room cleaning or disinfection is documented in the form of records. These are effectively room log books, which enable
the traceability of products or batches. In addition to confirmation that the work has been carried out, they also give a
status report on the room, which shows its cleaning status.

The type of production (product name, batch name for traceability) and the executed cleaning or disinfection are
documented (see Figure 11.D-5). Records that are hung up can be viewed easily, i.e. if they are hung up directly on site
(outside a room, as a record inside the room could potentially become contaminated or could act as a contaminant), so
that the cleaning status of a room can be seen directly from outside. The length of time for which this status can be
retained must be defined, above all from a microbiological perspective. This means that, as with production devices for
the production rooms, an expiration date for the cleanliness status must be defined.

The records should be checked in regular intervals by the head of department and compared with the current status.
During monitoring, they should be critically reviewed in terms of their quality. The retention time for this data, as
pharmaceutical secondary documentation, is the expiration time of the products produced in the rooms plus one year (at
least 5 years).

Figure 11.D-5 Example of a room cleaning record

Logo GMP Pharma

Acc. to SOP
Room cleaning record xyz Room no. C003

No
. Product Batch number Cleaning Disinfection Disinfectant group Signature
Note: After 14 days, cleaning/disinfection must be carried out again

Explanation
No.: Serial numbers mean completeness can be checked quickly
Product: Product name
Batch number: Batch ID for unique identification
Cleaning: Recording of the date of cleaning
Disinfection: Recording of the date of disinfection
Disinfectant: Documentation of the disinfectant used
Signature: Identification of the executor

11.D Summary
In the sanitation programme, the rooms are assigned to the cleanliness grades. The sanitation programme also
regulates what should be cleaned or disinfected, how often, with what means and how.
The sanitation programme relates exclusively to the cleaning of rooms and non-product contact surfaces. Associated
documents are the room cleaning instructions and the room cleaning records.