Affygility Solutions services

Virtual Risk Assessment for Potent Compound Safety and Handling. Risk assessments for potent compound safety handling and design review are critical for laboratories, pilot plants, manufacturing plants, and packaging and labeling facilities. Selecting a qualified occupational health and safety consulting firm to conduct the risk assessment is vital. There are several top factors listed below that qualify Affygility Solutions as your occupational health and safety service partner.

The potent compound safety experts at Affygility Solutions understand that your business is becoming more global each day, and Affygility Solutions is here to assist your company no matter where you are located in the world. We have direct experience in assisting companies in North and South American, Europe, the MENA region, India, and Asia.

On 19th April 2018, the European Medicines Agency (EMA) issued a revised copy of their "Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)"  hereafter, known as "the guidance." Of particular interest in the guidance is Q4.

Have a pharmaceutical product that needs a formal genotoxic and carcinogenic impurity assessment to meet the requirements of ICH M7? The expert toxicologists at Affygility Solutions can assist your company.

Categorization and placement of active pharmaceutical ingredients into control bands is an important step in the drug development process and a necessary part of any potent compound safety program. In addition, the European Medicines Agency (EMA) has recently required the development of acceptable daily exposure (ADE) values—also known as permissible daily exposure (PDE) values—for active pharmaceutical ingredients. In most cases a preliminary assignment of a potent compound should occur shortly after the decision to pursue development has been determined. Affygility Solutions` experienced industrial hygiene and toxicology professionals can determine the proper control band assignment, occupational exposure limit, and acceptable daily exposure value for your APIs.

Risk-MaPP — The Overall Goal; In 2010, the International Society of Pharmaceutical Engineers (ISPE) released Volume 7 of their Baseline Guide series: Risk-based Manufacture of Pharmaceutical Products, A Guide to Managing Risks Associated with Cross Contamination, or simply Risk-MaPP. The overall goal of Risk-MaPP is to provide a scientific, risk-based approach to managing the risk of cross product contamination in multi-product facilities.

Whether you are just getting started, or need to revamp a former potent compound safety program, the experts at Affygility Solutions can design and implement a potent compound safety program that will meet your company`s unique needs.

As active pharmaceutical ingredients (API) become more potent, the need for the validation of engineering controls and containment devices becomes imperative. Containment validation is a critical component of any potent compound safety program. Containment validation can be performed using a variety of methods, however, the most common method is to mimic the actual process using a substitute or surrogate compounds. Affygility Solutions has significant experience in containment evaluation of powders weighing enclosures, glove boxes, hard and flexible containment as well as other types of engineering controls.

Environmental Health and Safety (EHS) audits are a proven tool that will enhance a company`s EHS and business performance. It is standard practice among biotechnology, pharmaceutical, and medical device companies to conduct periodic audits. Affygility Solutions can provide comprehensive audits that are tailored to a clients specific objectives.

The complex work environment of the biotechnology, pharmaceutical, and medical industry creates special challenges for assessing occupational exposures. These challenges arise from the use of proprietary substances without established occupational exposures limits, batch process operations, and the increasing demand for moving products from development to market. Affygility Solutions can assist its clients in prioritizing exposure assessment needs, conducting monitoring, and interpretation of results. All samples are analyzed by an American Industrial Hygiene Association accredited laboratory.