Services

Affygility Solutions provides a broad range of environmental, health and safety consulting services to the life science industry, including:

• Environmental Health and Safety Auditing

  Environmental Health and Safety (EH&S) audits are a proven tool that will enhance a company's EH&S and business performance. It is standard practice among pharmaceutical companies to conduct periodic audits. Affygility Solutions can provide comprehensive audits that are tailored to a clients specific objectives. These objectives can include:

  • Identify areas of risk and potential loss;
  • Assess the effectiveness of EH&S management systems;
  • Identify opportunities for continuous improvement; and
  • Assess compliance with regulatory requirements and corporate standards.

  Unlike many EH&S audits, Affygility Solutions applies business concepts to EH&S audits.

• Potent Compound Risk Assessments

  Affygility Solutions has significant experience in performing risk assessments, determining occupational exposure limits, and classifying active pharmaceutical ingredients. We can provide assistance in helping your company develop and implement a cost-effective potent compound handling program.

• Management Systems

  Affygility Solutions is experienced in EH&S management systems to ensure sustainable compliance with regulatory and internal requirements. EH&S management system experience includes developing and implementing:

  • Overall corporate EH&S policy;
  • Global EH&S guidelines including categorization of pharmaceutical active ingredients, emergency management, EH&S audits, and many others;
  • Peer assessment audit program and protocols;
  • Nonconformance and corrective action program;
  • Metrics programs; and
  • Development and implementation of a global EH&S Steering Committee.

• Exposure Assessments

  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 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. All final assessment reports contain the following information:

  • Executive summary;
  • Description of operations monitored;
  • Assessment rational and methodology;
  • Field notes and calculations;
  • Laboratory sample results;
  • Interpretation of results;
  • Conclusions and Recommendations; and
  • Employee notification letters, ready for submittal by client representative.

  All final reports are reviewed and stamped by an American Board of Industrial Hygiene Certified Industrial Hygienists. Affygility Solutions is experienced in conducting air monitoring for a variety of substances common to the biotechnology, pharmaceutical and medical industry. These substances include: acetonitrile, ethylene oxide, formaldehyde, methanol, methylene chloride, pharmaceutical active ingredients, pyridine, waste anesthetic gases, and many other substances. Please contact Affygility Solutions to discussed your specific needs.

• Training

  Affygility Solutions can develop and conduct a wide variety of training courses to ensure compliance with OSHA and EPA requirements. These courses include:

  • Bloodborne Pathogens
  • Chemical Hygiene
  • Confined Space Entry
  • Emergency Response Initial and Refresher Training that is tailored specifically to the type of hazards and situations found in the laboratory environment
  • Lockout / Tagout
  • Hazardous Wastes Annual Refresher
  • Hazard Communication
  • Industrial Hygiene Air Monitoring
  • Respiratory Protection
  • Occupational exposure to pharmaceutical active ingredients

  Our customized training courses can be delivered on-site or online, via our web-based training offerings.