Baxter Healthcare Corporation
Irvine Manufacturing (English)
Baxter Healthcare Corporation
Irvine Manufacturing (English)
George Zack
Two Harbors Consulting
Laurie McQueen
Benchmark
2021/09/30
2024/09/30
Irvine Manufacturing
CMMI V2.0 Development - Capability Level
34.5%
50%
Pump, Infusion, Pca - Multirate Infusor LV; Multirate Infusor SV
OU Project
Lightweight, disposable devices with elastomeric technology that infuse medication solutions for ambulatory infusion therapies Technology: Pressure of the elastomeric component pushes fluid through flow restrictor.
85
IRVINE, , CA United States
Pump Manufacturing
Pump, Infusion, Elastomeric - Multirate Infusor LV; Multirate Infusor SV
OU Project
Lightweight, disposable devices with elastomeric technology that infuse medication solutions for ambulatory infusion therapies Technology: Pressure of the elastomeric component pushes fluid through flow restrictor.
85
IRVINE, , CA United States
Pump Manufacturing
Pump, Infusion, Elastomeric - Baxter Pain Mate Pain Mgt System; Multirate Infusor LV; Multirate Infusor SV
OU Project
Lightweight, disposable devices with elastomeric technology that infuse medication solutions for ambulatory infusion therapies Technology: Pressure of the elastomeric component pushes fluid through flow restrictor.
85
IRVINE, , CA United States
Pump Manufacturing
Pump, Infusion, Pca - Infusor Patients Control Module, 2 ML
OU Project
Lightweight, disposable devices with elastomeric technology that infuse medication solutions for ambulatory infusion therapies Technology: Pressure of the elastomeric component pushes fluid through flow restrictor.
85
IRVINE, , CA United States
Pump Manufacturing
Pump, Infusion, Elastomeric - Infusor SV & LV Elastomeric Infusion Devices
OU Project
Lightweight, disposable devices with elastomeric technology that infuse medication solutions for ambulatory infusion therapies Technology: Pressure of the elastomeric component pushes fluid through flow restrictor.
85
IRVINE, , CA United States
Pump Manufacturing
Pump, Infusion - Baxter Infusor LV; Baxter Infusor SV
OU Project
Lightweight, disposable devices with elastomeric technology that infuse medication solutions for ambulatory infusion therapies Technology: Pressure of the elastomeric component pushes fluid through flow restrictor.
85
IRVINE, , CA United States
Pump Manufacturing
Pump, Infusion, Elastomeric - Baxter Infusor LV; Baxter Infusor SV
OU Project
Lightweight, disposable devices with elastomeric technology that infuse medication solutions for ambulatory infusion therapies Technology: Pressure of the elastomeric component pushes fluid through flow restrictor.
85
IRVINE, , CA United States
Pump Manufacturing
Leadership Team
Organizational Project
Provides site leadership, sets objectives, drives accountability, provides HR, Finance, Training support, IT
11
IRVINE, , CA United States
Supply Chain
Organizational Project
Provides oversite of supply stock, manufacturing needs from corporate
4
IRVINE, , CA United States
Quality Mangement
Organizational Project
Provides quality and regulatory oversite
30
IRVINE, , CA United States
The Baxter Irvine facility is a manufacturing plant. It manufacturers medical devices for export from the US only, The Irvine facility is 94,865 square feet, with two ISO 8 cleanrooms (15,800 sq. ft) and a 18,000 square foot warehouse. The primary mode of manufacturing is rubber compounding and extrusion to create a FDA Class II devices. These are the Infusor Product Line, The Intermate Product Line, and the Multi-rate and PCM subassembly. These products allow the administration of infused products for oncology care, pain management and antibiotics. More specifically, these include: Pump, Infusion, Pca - Multirate Infusor LV; Multirate Infusor SV Pump, Infusion, Elastomeric - Multirate Infusor LV; Multirate Infusor SV Pump, Infusion, Elastomeric - Baxter Pain Mate Pain Mgt System; Multirate Infusor LV; Multirate Infusor SV Pump, Infusion, Pca - Infusor Patients Control Module, 2 ML Pump, Infusion, Elastomeric - Infusor SV & LV Elastomeric Infusion Devices Pump, Infusion - Baxter Infusor LV; Baxter Infusor SV Pump, Infusion, Elastomeric - Baxter Infusor LV; Baxter Infusor SV This can be referenced at the FDA Establishment Registration website at https://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/cfrl/rl.cfm?start_search=1&showList=1&establishmentName=Baxter®Num=&StateName=&CountryName=&OwnerOperatorNumber=&OwnerOperatorName=&ProductCode=&DeviceName=&ProprietaryName=&establishmentType=&PAGENUM=10&SortColumn=EstablishmentName20%25ASC&RegistrationNumber=2025695.
Type of Work: Type of work is a relevant sampling factor as Baxter Irvine work is focused on the manufacture of pump products.
Pump Manufacturing: Type of work is a relevant sampling factor as Baxter Irvine products are pumps manufactured at the facility.
Pump Manufacturing