Validation of sterilization processes

Requirement of the European Medical Device Directive (MDD) 93/42 ECC

Sterility of goods coming out of a sterilizer cannot be checked before use. To assure sterility
of products coming out of a sterilization process a validation process is required. It is required
to assure, that:

1 products coming out of the sterilization process are sterile with a sterility assurance
level of SAL 10
-6
CFU (according to EN 556)
2 reproducibility of sterility is guaranteed over a long time

Most people believe that sterilizers are validated and after this job is carried out necessarily
all products coming out of that sterilizer are always sterile. This is not correct. A sterilization
machine can never be validated but only a sterilization process.

Besides other details a sterilization process includes:
Cleaning
Disinfection
Functional check
Sterilization process including:
Sterilizer and supply media
Program used
Goods to be sterilized
Packaging material and packaging procedure
Storage
Transportation to the end-user
Quality Management System

All components working together define a sterilization process. If one important item of the
sterilization process is changed (e.g. a solid instrument against a complex minimal invasive
surgical (MIS-) instrument) this is a new process even if the same program is used.

Depending on the goods sterilized, their bio burden and packaging an adequate sterilization
program has to be designed according to the application. In healthcare standard programs
(steam 134C 3 min or 121C 15 min) are used. On top the kind of air removal and steam
penetration plays an important role to control how good the steam is penetrated inside the
packaging between the goods and inside hollow instruments and tubes. If instruments cannot
be sterilized at such high temperatures low temperature sterilization processes using
chemicals (ETO, formaldehyde, H
2
O
2
) can be used. All these sterilization programs can
sterilize and have advantages. But all of them have limitations too. These limitations must be
known and/ or be detected by carrying out a validation procedure.

A validation of a sterilization process is carried out in several steps:

1 Installation qualification (IQ)
2 Operational qualification (OQ)
3 Performance qualification (PQ)

1 Installation qualification (IQ)
When a new sterilizer is installed the company installing this machine has to make sure
that the machine is working according to the specifications agreed on when sold. The
selection of specifications is important to assure that the process is adequate to the
sterilized products later on.

For hospital sterilizers it is recommended to use a sterilizer according to EN 285. For small
sterilizers it is recommended to use a sterilizer according to EN 13060. Depending on the
type of products sterilized small sterilizer of type B, N or S has to be selected.

2 Operational qualification (OQ)
The operational qualification has to make sure that the sterilizer works correctly with all
the necessary components (like: cooling water, steam, electricity etc).

In steam sterilization processes one important part is the quality of the steam. The amount
of non-condensable gases in steam heavily influences the quality of the efficacy and
security of adequate steam penetration. According to the standards EN 285 and EN 13060
specific tests are carried to assure that the sterilizer is running according to its
specifications.

3 Performance qualification (PQ)
If the sterilizers run according to their specifications it is not automatically guaranteed that
all products are sterilized. Depending on the complexity of the products an adequate
sterilization program has to be selected. In steam sterilizers, the air removal and steam
penetration of that sterilization processes is absolutely important and must be adapted to
the type of instruments, the packaging and load configuration. This process must assure
that all products coming out of the sterilization process are sterile according to EN 556
(SAL 10
-6
CFU). To assure this, specific tests have to be carried out using parametric
release, chemical and biological indicators at the right place, specific process challenge
devices (PCDs) and sometimes inoculation of the goods at the worst case with biological
indictor suspensions with the following biological evaluation after the sterilization.

Routine monitoring
After the sterilization has been carried out successfully it must be assured that the process
being validated once is afterwards running correctly the same way. To guarantee the
permanent reproducibility an adequate routine monitoring is necessary. Adequate means
that the type of monitoring selected heavily depends on the complexity of the sterilization
process.

In steam sterilization processes the temperature- and pressure/ time parameters are monitored
and recorded. Those parameters guarantee a minimum of security. However, those parameters
are not able to guarantee that the sterility is carried out in all areas of the chamber.
Unfortunately, in steam sterilization processes, the steam distribution inside the chamber is
not homogeneous. It heavily depends on several process parameters. Therefore the steam
penetration into the worst case areas of the process (usually the middle inside of hollow
instruments) needs to be monitored in addition. For these special cases so-called process
challenge devices (PCDs) including a chemical and/ or biological indicator are used for
routine monitoring.
Documentation
If a patient gets a nosocomial infection, it may be caused by several reasons. To exclude
nosocomial infection caused by non-sterile instruments both: the documentation of the
validation of the process and also the information of the protocols of routine monitoring must
be presented to assure sterility. This information must be documented for each batch and has
to be stored in the CSSD.

The above information must be patient related. To achieve this requirement double self-
adhesive labels with all necessary information may be used to be adhered at the pack. When
the package is used - the label from the pack may be transferred to the patients
documentation without any additional writing.


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