is the separation of the aseptic
process area from the operator
environment. For the first time,
the document clearly recommends
the use of appropriate barrier
technologies isolators and RABS
(Restricted Access Barrier Systems)
are considered equal. Hence,
pharmaceutical manufacturers
require at least RABS for the
approval of new products. They
must decide whether to retrofit
an existing cleanroom line or
invest in new filling equipment
that runs with isolator (or RABS).

This has triggered a high demand
for new machines and barrier
technology upgrades. Syntegon
offers both options and analyses
customer requirements in detail to
recommend the ideal solution.

Automation and robotics
To establish and maintain
sterility as required by Annex
1, pharmaceutical companies
must conduct a contamination
risk analysis and document it
with measures in the form of a
Contamination Control
Strategy (CCS).

Advanced equipment
makes an
important contribution
here. In the
second chapter
of Annex 1,
automation and
robotic systems
are highlighted
under the
heading “Appropriate
technologies”. By using these
technologies, gloves and
human intervention in barrier systems
can be reduced to an absolute
minimum or even eliminated.

An example is the new Versynta
microBatch from Syntegon, which
was engineered “Annex 1 ready”
from the start. The fully
automated isolator production
cell fills between 120 and
500 containers per hour with
virtually no product loss and
100 percent in-process control.

Glove interventions are no longer
necessary in this solution.

Environmental monitoring
Environmental monitoring is
another example of the influence
of Annex 1 and the development
of more automated solutions:
settle plates may be exposed to
cleanroom air for a maximum
of four hours and must then be
replaced to ensure consistent
sampling. Syntegon has launched
the patented Settle Plate Changer
(SPC) to perform these steps
automatically with a new robotic
handling unit. This significantly
reduces production interruptions
to only once a day and results
in noticeably higher machine
availability of up to 300 hours per
year. The SPC is available both with
the purchase of a new machine and
as a retrofit for existing equipment
and can also be seamlessly
integrated into all machines and
control systems from third-party
suppliers. Outlook
The new Annex 1 is changing
sterile filling significantly. Many
new, mandatory details require
innovative solutions, while advances
in automation enable further
optimisations. If all players – from
pharmaceutical manufacturing
companies to inspectors to
equipment suppliers – work
closely together and learn from
each other, Annex 1 will fulfil its
intention: providing patients around
the world with the highest quality
medicines. www.syntegon.com
CHP PACKER INTERNATIONAL update 11