Pharmaceutical
& Medical Device
Contract Manufacturing
The operational centerpiece of a medical device or pharmaceutical supply chain.
360° Integrated Infrastructure
Product Development & Design
for Manufacturing (DFM)
Materials Selection, Production Process Development, Manufacturing Incubation, Custom Components & Features, Sterilization Compatibility & Services, and Quality Test Methods.
Medical Devices
Manual and Automated Assembly, Injection Molding, Tubing & Film Extrusion, RF Welding & Thermosealing, ETO Sterilization, and more.
ETO Sterilization Services
Ethylene-Oxide Sterilization Processing, Sterilization Cycle Development & Optimization, and Lab Testing Services.
Combination Products
Pharmaceuticals, Medical Devices, and the Expertise to Combine Capabilities into a Finished Product.
Pharmaceuticals
Aseptic Blow-Fill-Sealing, Drug Bag Filling, Injectables, Oral Solutions, Oral Solids, Lyophilized Powers, Packaging, and more
Pharmaceuticals
Aseptic Blow-Fill-Sealing, Drug Bag Filling, Injectables, Oral Solutions, Oral Solids, Lyophilized Powers, Packaging, and more
Medical Devices
Manual and Automated Assembly, Injection Molding, Tubing & Film Extrusion, RF Welding & Thermosealing, ETO Sterilization, and more
ETO Sterilization Services
Ethylene-Oxide Sterilization Processing, Sterilization Cycle Development & Optimization, and Lab Testing Services.
Product Development & Design
for Manufacturing (DFM)
Materials Selection, Production Process Development, Manufacturing Incubation, Custom Components & Features, Sterilization Compatibility & Services, and Quality Test Methods.
360° INTEGRATED INFRASTRUCTURE
Pharmaceutical Capabilities
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With over 18,000 employees dedicated to the manufacturing of complex pharmaceutical devices, PiSA offers US companies a world-class outsourcing solution for drugs, solutions, and combination devices. Some examples include – Injectable & Oral Solutions, Oral Solids, Lyophilized Powders and more.
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PiSA has twenty-five (25) blow-fill-seal lines that produce & aseptically fill ampoules, vials, and bottles. Additionally, PiSA offers automated and semi-automated packaging solutions for finished devices. For more information, contact info@pisa-usa.com.
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Vertically integrated with film extrusion and RF welding & thermosealing capabilities – PiSA produces over eighty (80) million bags per year. These bags are filled in-house with drugs and/or solutions, and final packaged.
Oncology Capabilities
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PiSA’s Oncological and Immunosuppressant Manufacturing facility can currently produce 10 million doses of injectables and 500 million doses of oral solids annually. PiSA’s Immunosuppressant facility has the capacity to produce 200 million capsules, tablets, and vials.
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PiSA has invested in state-of-the-art, cutting-edge equipment to ensure quality and reliability for high volume manufacturing. These include, automated mixers, grinders, tablet and capsule formulation, blister pack systems, independent HVAC and water purification systems, automated cleaning systems, magnetic stirring, vaporized hydrogen peroxide generators and two 200 sq. ft. Lyophilization systems.
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Containment is the key consideration when manufacturing these pharmaceuticals for safety and prevent cross contamination. The entire facility operates at Occupational Exposure Band 5 to ensure operator health and safety. All processes are hermitically sealed, using sampling isolators and active weighing and integrate hermetically sealed bins. Automated Clean-in-Place and Wash-in-Place Systems ensure zero cross contamination.
Medical Device Capabilities
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Vertically integrated with over two hundred (200) Plastics Injection Molding Machines, twenty (20) Film & Tubing Extrusion Lines, and three (3) Ethylene Oxide Sterilization Facilities, PiSA offers an industry-best outsourcing solution for medical devices.
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PiSA operates three (3) Ethylene Oxide Sterilization Facilities in Mexico, including the new Centerpiece Sterilization facility located in Tijuana, Mexico. The Centerpiece ETO Sterilization Facility has been widely recognized for its high-quality processing equipment and cutting-edge emissions control technology.
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New product design & development capabilities are essential for innovation and commercial growth. PiSA offers custom product & component development, packaging design & configuration, and sterilization compatibility.
The operational centerpiece of a medical device or pharmaceutical supply chain.
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