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TechniKrom® provides pilot and production scale (lOμmol-lmole) 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 316Lss, Hastelloy Alloys and a full range of polymers
which can be utilized to withstand the demanding environment
of synthesis.
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. We are moving toward
ISO 9000 registration and follow industry guidelines such
as: ISPE guidelines (e.g. Gamp-4 and the Baseline Guide for
Commissioning and Qualification of New Mfg Facilities), ASME,
ASME-BPE, UL, NEC, IEEE, and FDA.
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 polymeric
tubing, fittings and valves (if desired).
• 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. This feature is also
used to control and record reagent and reactant loading into
the batch reports.
• Pressure sensor and transmitter provides automatic
pressure logging and emergency alarm and system pause for
high-pressure condition.
• Automatic, rcsumabic, safety pause of system in case
of user-defined alarm.
• Outlet manifold 1: sanitary low dead volume design
for automated reactor vessel/column bypass and waste, minimize
carry over and facilitate system cleaning.
• Post-reactor conductivity detector in a sanitary How
cell to provide automatic logging of conductivity data.
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