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The preparation of Compounded Sterile Products.

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Pharmaceutical Compounding
Solutions for unparalleled visibility into the preparation of Compounded Sterile Products.
In 2004, the United States Pharmacopeia issued chapter 797 “Pharmaceutical Compounding – Sterile Preparations” (USP 797), which provides the guidelines, procedures, and compliance requirements for compounding sterile preparations as well as setting the standards that apply to all parameters in which these tasks are performed. USP 797 promotes the protection of the sterility of the drug. In 2016 USP 800 “Handling Drugs in Healthcare Settings” was released. It provides standards for the safe handling of hazardous drugs in order to minimize contamination transfer to healthcare personnel, patients, the environment, and the drugs themselves. Baker is proud to provide support to pharmaceutical professionals in order to help them stay current on the latest issues about aseptic preparation of parenteral hazardous and non-hazardous drug products.

To optimize the validation and documentation of sterile compounding procedures, Baker integrates with a variety of IV workflow management systems as well as Pharmacy Verification Software. Built in fully integrated IV prep software keeps the compounding environment clean with no wires or devices within the hood. Usable compounding space is left unaltered. A powerful 5 megapixel imaging system that closely focuses in on the names, numbers, labels, color and other details of drugs and syringes is utilized.

The integrated systems include image recognition and barcode scanning features as well as a storage and retrieval image system that allows for documentation of the compounding process for quality purposes. The compounding status dashboard is automatically updated and easily accessible from desktops, laptops, tablets, and mobile devices. The integrated systems are scalable and modular allowing flexibility to adapt to the customer environment.

When working with hazardous pharmaceutical compounds, chemotherapy agents, or IV mixtures that can be harmful to pharmacy personnel, a contained and leak-tight negative pressure work area is required. Baker’s barrier isolator creates a unidirectional HEPA-filtered airflow of better than ISO Class 5 (class 100) air cleanliness conditions within the

negative pressure chamber to prevent migration of hazardous contaminants to the outside and minimize cross-contamination in the direct compounding area. Clean technology designs improve the pharmaceutical compounding process by offering the finest environmental protection to the pharmacy laboratory.

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About Baker
Baker maintains an unparalleled passion for helping our customers advance science, discovery, and clinical care.
The people of Baker have built that reputation by taking no chances with customers’ safety and making no compromises when it comes to protecting the success of your research. Baker’s laboratory products are built to order with precision craftsmanship and designed expressly for your unique application need. Our rigorous testing protocols go above and beyond what the average user would ever encounter and our quality control measures exceed industry standards. Our commitment to sustainable business practices and the development of a new generation of energy efficient products ensures that you — and your budget — will be pleased.