Qualitative Exposure Risk Assessment
- ISS developed pharma industry specific assessment tool or company recommended assessment tools.
- Detailed walkthrough for hazards identification and exposure potential determination.
- Outcome is risk characterization and robust exposure monitoring plan.
- Recommendations and best practices shared for reducing risk.
Containment selection and validation:
- Employee exposure monitoring for APIs, solvents, surrogates, endotoxins, animal allergens.
- API specific monitoring and analytical methods with lowest limits of quantitation and highest API sensitivity.
- Use of IOM samplers or standard filter cassettes depening upon monitoring requirements.
- Most suitable Surrogate selection for APIs using globally accepted guidelines.
- Special handling, storage and shipping of samples to prevent cross-contamination and maintain samples' stability.
- Wipe sampling for determining spread of contamination or cleaning efficiency.
More than 5000 API and surrogate monitoring samples collected across pharmaceutical facilities.
Containment selection, qualification, validation:
- Assist in containment selection based on API hazards and tasks performed.
- Conduct Factory acceptance and site acceptance validation studies.
- Develop containment verification plans using industry accepted validation protocols.
200 + devices validated globally - Isolator, flexible film containment, ventilated enclosures and contained transfer systems.
Co-hosted annual pharmaceutical forum at American Industrial Hygiene conference, presented on statistical interpretation of various containment performance devices.
Potent compound handling:
- Assistance during design/upgradation of facilities to minimize exposures and spread of contamination
- Develop zoning , safe gowning/de-gowning and waste handling procedures
- Develop task-specific work practice controls.
- Supply chain audits and due diligence at 100+ API manufacturing and formulation facilities globally.
- Auditors with considerable pharma experience.
- Evaluation against regulatory requirements, global best practices and company guidelines
- Assisting facilities in implementation of corrective actions.
Conducted supply chain EHS audits and due diligence at more than 100 third party manufacturing sites in India, China, Ireland, USA and Germany.
Process Safety Management:
- Safe handling of solvents and flammable chemicals
- Ignition sources and controls
- Dust explosion potential and controls
- Inerting and validation
- Dispersion modelling
- Pressure reliefs design consideration
Cross contamination studies:
- Employee and product protection at facilities handling multiple APIs
- Ventilation system design review and pressure gradients between corridor, change rooms and production areas.