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TechniKrom® provides pilot and production scale (10 μmol –
1 mol) automated synthesis units for use in the Biopharmaceutical,
Pharmaceutical and Fine Chemical Industries.
Our Synthesizers are custom built
around our standard technology platform and designed in accordance
with GAMP-4 guidelines to meet client User Requirement Specifications,
accommodating the specificity common with most synthesis needs.
Synthesizers are designed for amino acid or amidite use with
appropriate solvents and reagents, depending upon application.
A variety of compatible Materials of Construction (MOC) are
available including 316L ss, Hastelloy Alloys and a full range
of polymers which can be utilized to withstand the demanding
environment of synthesis.
TYPICAL FULLY AUTOMATED BIO-SYNTHESIZER:
The unit is sanitary, cGMP designed,
portable skid mounted system with low dead volume path appropriate
for both multi-product and dedicated cGMP syntheses. Features
normally include, but aren't limited to those indicated below.
• Solvent and acid/base resistant 316L
stainless steel or polymeric tubing, fittings and valves.
• Low dead volume controlled inlets for reagents, amino
acids, amidites, and solvents.
• Triple Head Teflon Diaphragm Metering Pumps: Appropriate
pump sizes with turndown capability, stroke length adjustment,
variable frequency drive and high precision industrial design
features.
• Flowmeter(s) downstream of pumps to provide feedback
to keep flow rate accurate while submitting real time flow
rate documentation into batch reports.
• Pressure sensor and transmitter holds a specified setpoint
and enables emergency alarm and system pause for high-pressure
condition.
• Automatic, resumable, safety pause of system in case
of user-defined alarm.
• Outlet manifold is of sanitary low dead volume design
for automated reactor vessel/column bypass and waste; minimizes
carry over and facilitates system cleaning.
• Post-reactor conductivity detector in a sanitary flow
cell to provide automatic logging of conductivity data.
The same level of quality found in
our system skids is present by using comparable or identical
valves, pumps and EX components where needed and fully 21
CFR Part 11 capable process control software.
Best in the industry, well-organized
and comprehensive
• Designed to meet FDA recommended
protocols and requirements
• Cuts your validation timeline from months to days.
TechniKrom designs, builds and tests
all equipment in accordance with FDA, ISPE GAMP-4, ASME-BPE,
UL, and international codes (e.g. ATEX). A project engineering
manager coordinates each project and works with you directly,
from the design phase to the final installation and training.
Built on industrial 316L stainless
steel platforms, all systems are manufactured with the highest
level of validated sanitary design. They include individually
PIN stamped components, boroscoped piping welds, 21 CFR Part
11 process control systems (customer specified or Delta V,
Allen Bradley, etc.)
Comprehensive IQ/OQ validation package
includes Technikrom's world-class validation protocol and
system documentation. The validation package provides detailed
testing reports on all IQ/OQ validation procedures (over 200
tests) as well as all component manuals, test certificates
and documentation. Our clients have been able to cut validation
times from months to days using our validation package.
We pride ourselves on the fastest delivery times in the industry.
One year extendable warranty, service contracts and 24 hour
response time in the United States means peace of mind and
quick support when you need it.
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DNA,
RNA and Peptide Synthesis