Pentec Health’s prescription-based 503A sterile compounding facility provides protein therapies to meet the nutritional needs of malnourished dialysis patients and medications for patients with implanted intrathecal pumps. It features two cleanroom complexes having separate HVAC units with environmental controls to minimize airborne contamination. The facility recently passed a U.S. Food and Drug Administration (FDA) inspection resulting in no observations and no issuance of a Form 483, further endorsing our commitment to our 503A operation and excellence.
Pentec Health’s 503A facility meets the requirements of state, federal and international agencies including the FDA, the National Association of Boards of Pharmacy, the Pennsylvania State Board of Pharmacy and the Joint Commission. We are also approved by the International Organization for Standardization (ISO) and are re-certified every six months to meet its classification for compounding standards and ensuring compliance with stringent USP <797> guidelines.
Additionally, our Pharmacy and Quality teams collaborate diligently to guarantee the accuracy and quality of our compounded preparations. They also maintain the integrity and sterility of the compounding environment by performing daily environmental monitoring, monthly air and surface sampling, monthly fingertip testing, semi-annual media fill validation and biannual evaluation of compounding personnel.
Our 503A facility helps meet the nutritional needs of dialysis patients and is a key component to the exceptional care we provide to patients having implanted intrathecal pumps.
Pentec Health compounds patient-specific Intradialytic Parenteral Nutrition (IDPN) and Intraperitoneal Nutrition (IPN) therapies that are custom-prepared to meet the specific protein therapy needs of malnourished dialysis patients. More than three decades of precision and reliability have earned us
the trust of nephrologists nationwide.
Pentec Health is an industry leader in providing and administering physician-prescribed, patient-specific compounded sterile medications. Our team of highly trained registered nurses is available 24/7/365 to provide personalized in-home care, comprehensive physical assessments and emotional support.
See for yourself why doctors and patients count on our facility’s dedication to sterility, safety, and efficiency. Contact us today to schedule a guided tour!
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50 Applied Card WayGlen Mills, PA 19342
P : (610) 494-8700
120 Forbes Boulevard, Suite 140Mansfield, MA 02048
P : (855) 217-5541 F : (508) 261-7102
4 Creek ParkwayBoothwyn, PA 19061
P : (800) 223-4376 F : (800) 355-1029
Proudly Quality Accredited
National Quality Approval – The Joint Commission
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