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Kruse Controls,
Inc. has been providing validated automation systems for the
pharmaceutical and biotechnology industries for years.
Our automation
systems typically utilize programmable logic controllers (PLCs)
for logic control. We have, however, utilized direct PC control
when requested by the customer and where it made sense. Our
systems often utilize human-machine interface (HMI) products to
provide operators with control and monitoring capabilities. We
have designed automation systems for a diverse group of
applications, including:
Where dynamic
batch recipe control and extensive batch archiving were
required, we have provided ISA S88 compliant
batching systems
using off-the-shelf products customized for the specific
application.
Where data
acquisition and storage were required, we
provided database servers and I/O structures to gather process
information and store it in reliable and efficient tables.
Automatic report generation via printers, email or intranet is
provided when required.
At Kruse
Controls, Inc., we are familiar with the cGMP guidelines
required for FDA validation. Our design and implementation
process allows us to provide well-documented systems that can be
easily validated for the FDA. We have passed customer audits
that examined our design and documentation procedures to help
ensure future validation success.
The recent FDA
emphasis on 21 CFR 11 compliance places a premium on companies
with control, data handling and validation compliance
experience. Kruse Controls, Inc. is experienced in all
these areas and has helped several customers meet 21 CFR 11
compliance. Kruse Controls, Inc. can provide 21 CFR 11
compliance audits, recommend and implement 21 CFR 11 compliance
strategies and provide validation for 21 CFR 11 compliant
systems.
Whether you
require validated full-scale production automation, validated
data collection or 21 CFR 11 expertise, Kruse Controls, Inc.
can be your sole source solution.
Project Examples
USP Water
Purification/Batching System
SUMMARY:
Replaced the existing control system on a pharmaceutical USP water purification
system with a new PLC/HMI based system allowing password security and access,
operator interface for setup, process parameter configuration and alarm
annunciation. System controls monitored various quality devices (rupture disks,
filter pressures, temperature and UV status) as well as conductivity and TOC.
Design and Installation of a
spray dryer control system for a
pharmaceutical manufacturer
SUMMARY:
A PC-based control package and (HMI) workstation were used to provide control of
a spray drying process.
Turn-key Design and
Installation of a batching process for a
pharmaceutical manufacturer
SUMMARY:
A programmable logic controller (PLC) was used to control the batch
manufacturing process in a hazardous (Class 1, Division 2) location. A human
machine interface (HMI) workstation and an operator interface terminal (OIT)
were used to provide system status and allow operators to control the batch.
Turn-key Design and Installation
of a clean room air handling system for a
pharmaceutical
manufacturer
SUMMARY:
A programmable logic controller (PLC) was used to control the clean room air
handling system. Two human machine interface (HMI) workstations were used to
provide system status and allow operators to change system setpoints.
Development and Installation of a
batch control system using ISA S88.01
compliant batch software
SUMMARY:
Used a programmable logic controller (PLC) and batch control software that is
compliant with the ISA S88.01 batch control standard to control a batch process
for a food flavorings manufacturer.
Packaging Line Integration
SUMMARY:
Networked all OEM PLCs to establish supervisory control over the entire
packaging line.
Automation of
In-line Filler for Pharmaceutical Industry
SUMMARY:
PLC program development for 2 separate In-line fillers, one for
1.0 to 45 Oz Nasal Spray and the second for Pint size bottles. Also
included OIT and Servo controllers.
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