What is SMEPAC
In the pharmaceutical industry, SMEPAC refers to a standardized method for evaluating airborne particulate emissions from pharmaceutical containment systems. Developed by ISPE, it is a recognized technical framework for assessing equipment containment capabilities, protecting personnel safety, and maintaining environmental cleanliness.
Application Scenarios
Adapt to FAT/SAT acceptance of new equipment, verifying whether the containment performance of isolators, alpha-beta valves and related systems meets target standards.
Support periodic risk assessment of existing facilities and identify potential dust leakage hazards.
Assist in safety gap analysis when introducing high OEB level APIs to ensure operational compliance.
Match re-validation after process changes to maintain risk control throughout the production lifecycle.
SMEPAC Sampling Process
1. Test Preparation
Define CPT and OEB targets, select surrogates (e.g., lactose or naproxen sodium), and finalize sampling locations, instruments and cycle times.
2. On-site Sampling
Deploy air samplers, simulate routine production operations, and collect wipe samples at representative locations.
3. Sample Analysis
Perform quantitative analysis of air and wipe samples (e.g., using HPLC) in an AIHA-accredited laboratory.
4. Result Reporting
Compare results with CPT/OEL limits, conduct statistical evaluation, and provide actionable improvement recommendations.
Our Advantages
Our core consulting team is highly qualified. All members graduated from universities ranked in the Top 100 QS World University Rankings and have years of dedicated experience in industrial hygiene. They have accumulated rich practical experience in pharmaceutical dust testing and risk management, capable of accurately addressing testing needs in various complex production scenarios.
What's more, we have the only AIHA (American Industrial Hygiene Association) accredited pharmaceutical dust industrial hygiene laboratory in Asia. With this accreditation, our testing processes are fully aligned with international standards, and data results are globally recognized. Meanwhile, relying on standardized operating systems and professional technical capabilities, we can significantly improve analysis efficiency while optimizing testing costs, allowing customers to enjoy cost-effective solutions and faster report delivery while obtaining authoritative testing services.
