USP 797 Pharmaceutical Compounding – Sterile Preparation

The U.S. Pharmacopeial Convention General Chapter 797 describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations.

USP 800 Hazardous Drugs – Handling in Healthcare Settings

The U.S. Pharmacopeial Convention General Chapter 800 is a proposed revision to USP 797 addressing practice and quality standards for handling hazardous drugs (HDs) to promote patient and worker safety, and environmental protection.

NIST - National Institute of Standards and Technology

NIST, a non-regulatory agency of the U.S. Department of Commerce, is a measurement standards laboratory. Their research helps to advance the nation’s technology infrastructure and helps facilities improve their products and services.

FDA Compounding Quality Act

Title 1 of the Drug Quality and Security Act of 2013, the Compounding Quality Act, removes certain provisions from section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA).

- FDA Pharmaceutical Quality/CMC Guidances
- FDA Pharmaceutical Quality/Manufacturing Standards (CGMP)
- JCAHO Gold Seal of Approval

The Joint Commission (JCAHO) strives to improve the quality of care and patient safety. Their Accreditation and Certification is recognized nationwide as a symbol of quality. Organizations must pass inspections based on regulatory compliance, and acceptance reflects their commitment to specific performance standards. Mission: To continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.

CDC Vaccine Storage & Handling Toolkit

To protect our communities, the CDC provides valuable health information and responds to dangerous health threats when they arise. They work to promote healthy, safe behaviors for our communities and environment, using science and technology to prevent disease. The National Institute for Occupational Safety and Health (NIOSH) provides information on how to protect communities by first protecting our employees.

ISO 9001:2015 Certified

ISO 9001 is the international gold-standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.

BACnet Enabled

BACnet is a communication protocol for Building Automation and Control networks that leverage the ASHRAE, ANSI, and ISO 16484-5 standard protocol.

Made in USA

As a USA-based manufacturing company, most of our products and software are designed and built in our Boxborough, MA plants. Quality in engineering and design is core to what we build.

RoHS Compliant

RoHS is a set of EU rules restricting the use of hazardous substances in electrical and electronic equipment to protect the environment and public health. Most Setra hardware products comply with RoHS.