Manufacturing facility expansion
Piramal Pharma Solutions (PPS) is expanding its manufacturing facility in Riverview, Michigan, with an investment of approximately $32m to develop and manufacture potent and non-potent active pharmaceutical ingredients (API).
Announced in December 2020, the expansion will incorporate innovative capabilities and increased capacity for a new laboratory and large-scale manufacturing.
The expansion should be complete for operations in June 2022. It will add approximately 20 new workers to the facility, increasing the overall number of employees to more than 180 and will support the regional economy.
PPS’ API manufacturing facility, located at Krause Street, Riverview, Michigan is well-known for high-potency active pharmaceutical ingredients (HPAPIs) manufacturing.
The facility will be expanded with the addition of more than 25,000ft2 that includes an 8,500ft2 production area to the existing facility.
It will be installed with new 4,000L reactors along with the addition of two new kilo laboratories for process development and GMP manufacturing for clinical trials up to 100L scale.
Other crucial equipment, including a 1m2 filters dryer with glove box technology, a 3KL and a 4KL mild steel glass-lined reactor, and a 3KL Hastelloy reactor will also be added to the facility. All equipment is designed to handle potent compounds with occupational exposure levels (OELs) more than 1mcg / m3.
The facility is designed with all necessary measures for safe handling of the highly-potent compounds, including controlled room pressurisation and airlocks for the safe movement of both persons and goods, scrubber for any off-gassing reaction and glove box technology or contained systems for charging and discharging of the powders.
The expansion will allow the company to meet the consumers’ immediate and long-term API needs, increasing its foothold in North America. It will improve the company’s ability to timely deliver quality active ingredients around the world.
The expansion marks the company’s seventh major acquisition or expansion in North America over the past six years.
PPS’ Riverview facility is compliant with regulatory norms, including those set by the US Food and Drug Administration (FDA) and several European and Asian government agencies. It maintains a high standard in health, safety and environmental sustainability.
The state-of-the-art Riverview facility is committed to manufacturing low OEL HPAPIs.
It is equipped with 4,000L glass-lined reaction vessels which can operate in a temperature range from -70°C to 200°C, high-potency manufacturing suites with airlocks and barrier isolation systems and reactor bays for large-scale HPAPIs.
The site features product insulation capabilities, including extraction, filtration, centrifugation, and distillation, as well as drying and finishing capabilities including enclosed Rosenmund glove-box filter dryers, forced air and vacuum drying ovens and class 10,000 clean suites.
Running for 12 hours a day through seven days a week and is heading towards becoming a full 24 / 7 site, the establishment holds 15 US Food and Drug Administration (FDA) approvals and has experience in breakthrough status, orphan diseases, and fast track approvals.
The site also offers featured services such as process research full-time equivalents (FTEs), optimisation, commercial API and HPAPI manufacturing, safety assessments, impurity identification, characterisation and synthesis, solid-state characterisation, analytical method development, qualification and validation.
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