WEPA TopiTec Automatic, Руководство пользователя

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10
TOPITEC
®
AUTOMATIC User Manual | 02-2020
2.1. Proper use / product description
• The TOPITEC
®
AUTOMATIC is designed for the production of semi-solid formulations (medicines,
ointments, creams, cosmetic products) in pharmacies.
During production, the jar containing the ingredients is moved up and down while the product
inside the jar (TOPITEC
® jar) is stirred by means of the mixer (tool shaft). The preparation of the
product (adding ingredients in the correct sequence to the jar) takes place outside the device.
Instruction by WEPA or WEPA sales partner.
• The TOPITEC
®
AUTOMATIC has been developed and designed exclusively for commercial
applications. Any private use of the TOPITEC
®
AUTOMATIC is forbidden.
• The TOPITEC ® AUTOMATIC is not designed for operation in potentially explosive atmospheres
(vapour or dust; ATEX; observe information in safety data sheets) or within a designated ATEX
zone as defined by the device owner.
2.2 Proper use / application
Mixing of prepared and sealed jars containing pH neutral pastes, ointments, creams or powders
that are not radioactive, explosive or flammable. The device is designed for use in pharmacies and
operation by suitably instructed personnel. The mixing of ingredients must not result in explosive
substances.
An instructed person (operator) is a person with a pharmaceutical qualification who is older than
18 years of age and has been instructed in the use of the device.
The substances, materials and media to be used for processing in the mixing system are to be
sourced by the device owner, who is responsible for the proper use of these substances. The device
owner is also responsible for the correct handling of these substances, materials and media, with
due regard to any associated risks. The device owner must provide safety and disposal instructions
for staff. Strictly observe the safety data sheets provided by the manufacturers of the materials /
media.
For safety and quality reasons, the device must only be used in conjunction with original
TOPITEC
® /aponorm ® containers. These containers are not gas-tight, so substances might leak out.
The device owner must ensure that all personnel wear the required personal protective equip-
ment. Compliance must be monitored.
Operating personnel must comply with all statutory regulations and observe the specific require-
ments for the processed substances.
Information regarding proper hygiene procedures can be found in the ApBetrO, the hygiene guide-
lines published by Gesellschaft für Dermopharmazie GD for the preparation of sterile pharmaceu-
tical products, the BAK Guidelines, statutory regulations, etc.