SIMATIC PCS 7 process control system
SIMATIC PCS 7 process control system
SIMATIC PCS 7 process control system
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<strong>SIMATIC</strong> BATCH<br />
Batch data archiving and logging in XML format<br />
The batch data which are only accessible to authorized persons<br />
or <strong>system</strong>s are saved in XML format. The Batch Report<br />
function provides an XML-based batch report as standard<br />
which can be displayed and printed by means of BatchCC or<br />
the protocol viewer. In addition, the XML data can also be <strong>process</strong>ed<br />
further by an external report <strong>system</strong>.<br />
Library with recipe operations (ROP)<br />
The management of recipe operations is conveniently supported<br />
by a user library (ROP library). Library recipe operations<br />
can be inserted as a reference in recipe procedures and can<br />
thus be modified from a central location. This reduces the requirements<br />
for engineering and validation. If the reference<br />
link is broken, the recipe operation becomes a fixed component<br />
of the recipe procedure, and is thus independent of further<br />
central modifications.<br />
Quantity<br />
Temperature<br />
Time<br />
Salt<br />
Pepper<br />
Sugar<br />
Formula 1<br />
1000 kg<br />
90 °C<br />
10 min<br />
Yes<br />
No<br />
100 g<br />
Formula 2<br />
500 kg<br />
80 °C<br />
15 min<br />
Yes<br />
No<br />
150 g<br />
Formula 3<br />
900 kg<br />
95 °C<br />
12 min<br />
No<br />
Yes<br />
50 g<br />
Validation according to 21 CFR Part 11<br />
The number of plants which have to be validated for observance<br />
of quality standards because of marketing and statutory<br />
requirements is permanently increasing. The <strong>process</strong> <strong>control</strong><br />
<strong>system</strong> and its manufacturer play an important role in the validation<br />
procedure.<br />
<strong>SIMATIC</strong> BATCH particularly supports validation according to<br />
21 CFR Part 11 through:<br />
■ Consistent standardization, e.g. with type/instance concept<br />
of the SFC, recipe creation independent of plant unit,<br />
isolation from procedure and formula, library recipe operations<br />
■ Audit trail (modification logbook):<br />
- Recording of changes in recipes and recipe operations<br />
(saved with modified object)<br />
- Recording of changes during production (in the batch<br />
report), including the<br />
- operations at the individual <strong>control</strong> level belonging to<br />
the corresponding batch<br />
■ Version assignment (lifecycle of recipes, recipe operations,<br />
formulae)<br />
■ Central user administration with access <strong>control</strong> through<br />
<strong>SIMATIC</strong> Logon<br />
■ Electronic signature for release of master recipes, formulae<br />
and library objects based on <strong>SIMATIC</strong> Logon<br />
Furthermore, Siemens as a manufacturer of <strong>process</strong> <strong>control</strong><br />
<strong>system</strong>s has specially trained personnel as well as many years<br />
of experience in quality management and plant validation.<br />
Master Recipe #1<br />
Master Recipe #2 Master Recipe #3<br />
MIS/MES interfacing<br />
Interfacing of MIS/MES <strong>system</strong>s is supported by:<br />
■ Integration of <strong>SIMATIC</strong> <strong>PCS</strong> 7 into <strong>SIMATIC</strong> IT<br />
■ An open interface (API) for customized expansions.<br />
Separation of procedure and formula<br />
Separation of procedure and formula<br />
The flexibility achieved by recipes which are independent of<br />
plant units can be increased even further if the procedure and<br />
parameter sets (formulae) are separated from one another.<br />
Various master recipes can be created by linking several formulae<br />
using a recipe procedure. This enables central modification<br />
of procedures. The formula structure is determined by<br />
the formula category defined by the user.<br />
36 <strong>SIMATIC</strong> BATCH