Of the many projects we have undertaken, the following illustrate the range and diversity of what we do in the field of contained pharmaceutical processing. For a complete project list click here.
Merck
Review of A/E and vendor designs for reactor charging. PharmaConsult US
redesigned the containment system and conducted ergonomic evaluation of
the redesign including a full size model that the operators tested against
the operations required. Modifications due to the ergonomic evaluation
were incorporated into the final design. This exercise saved Merck approximately
$550,000. Merck currently replicates this design in other areas.
Novex Canada
Design of a non-potent aseptic vial filling. PharmaConsult US was contracted
by a Canadian design firm to provide the isolator design for
a new filling facility for Novex. PharmaConsult US provided conceptual
design and
User Requirement Specifications for the project.
Pfizer Groton
Upgrade of a 40+ year old API pilot plant to handle potent drug substances.
The design exposure level was 30 nanograms/m3/8 hours. The processes
included charging, subdivision and filter dryer off-loading. PharmaConsult
US provided
a full range of services from Options and Recommendations through
Operator Training. The surrogate test results indicated that the
system performs
better than the design level.
Client’s representative for the implementation, surrogate testing and training for an R&D wet chemistry facility. PharmaConsult US reworked the bagging out system to help the system meet the design performance levels. PharmaConsult US also assisted in expediting the system completion and delivery.
Sanofi-Synthelabo Malvern
PharmaConsult US provides full isolator service for Sanofi-Synthelabo’s
R&D site in Malvern, PA. Sanofi-Synthelabo currently has isolators
for toxicology, analytical and API production. PharmaConsult US
designs, supports,
maintains and performs routine performance monitoring for all these
isolators.
Wyeth Guayama
Retrofit of a 25+ year old OSD facility (1200 liter scale) to handle
potent API’s. The processes included subdivision, granulation,
fluid bed drying, blending, milling, tableting and coating. PharmaConsult
us provided
a full range of services from Options and Recommendations through
Operator Training including assistance in the process equipment selection.
The
surrogate test results ranged from non-detectable to .30 micrograms
with a TWA of
8 hours.
Wyeth Pearl River
Design of a conjugation, derivatization and purification containment
system for a potent biotech entity in a complex process involving
prep HPLC,
reaction and vacuum tray drying. With multiple chambers and glassware
up to 30 liters.
The process has 400+ steps. PharmaConsult US provided Options and
Recommendations report, Design Development, Bid Documents including
General Arrangement
and P&ID drawings and Vendor support.
Evaluate product loss from dust collection waste. The evaluation identified areas of product loss and indicated reduction in waste costs by containing the product in the product boundary so that saleable product is not sent to expensive waste.
