Project Profiles

Affygility Solutions has significant experience in delivering a wide-variety of environmental, health, and safety (EHS) solutions to our clients in the biotechnology, pharmaceutical, and medical device industry. Listed below is a small sample of the types of EHS, occupational toxicology, and industrial hygiene projects that our industry-experienced professionals have performed.

Computer Based Training (CBT) in Potent Compound Safety

A major pharmaceutical manufacturer that handles a wide variety of Category 4 and Category 5 potent compounds needed a computer-based training (CBT) program in potent compound safety to provide environmental, health and safety (EHS) training to new employees. The experts at Affygility Solutions responded to this need by developing a customized CBT program.

Containment Validation and Surrogate Monitoring

A pharmaceutical contract manufacturer that handles a wide variety of early stage active pharmaceutical ingredients needed to have their engineering controls and administrative practices validated. Working with Company personnel, Affygility Solutions conducted surrogate monitoring and defined the level of control offered by current systems.

EH&S Information Management Tool Implementation

A 2,000-plus person research institution needed a simple, affordable environmental, health and safety management tool to manage their complex regulatory requirements. Affygility Solutions identified all EH&S related regulatory requirements, populated requirements, and implemented Affytrac in less than 1 week.

Material Safety Data Sheets

A mid-sized pharmaceutical company needed several dozen material safety data sheets (MSDS) developed. Affygility Solutions met the client’s need by developing the requested MSDSs within the client’s required timeframe.

On-site Environmental, Health and Safety Services

A biotechnology company engaged in the discovery, development, and commercialization of novel antibiotics needed ongoing environmental, health and safety support. Affygility Solutions responded by providing on-site personnel to provide turnkey EH&S support.

Potent Compound Classification Reports

A large, international pharmaceutical manufacturer with multiple products in development needed their active pharmaceutical ingredients classified into a control banding scheme. Affygility Solutions responded to the client’s needs and prepare comprehensive potent compound classification monographs within the client’s timeframe and budget.

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