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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

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