EPA 1671 PMI Testing

EPA Method 1671

This method is for surveying and monitoring under the Clean Water Act. The method is used to
determine certain non-purgeable volatile organic pollutants specific to the pharmaceutical
manufacturing industry (PMI) that are amenable to direct aqueous injection gas chromatography
(GC) and detection by a flame ionization detector (FID).

Teklab is a NELAC accredited environmental testing laboratory that provides specialty analysis such as those required for pharmaceutical effluent. EPA 1671 includes the following compounds, as well as others;

→The Environmental Protection Agency (EPA) has defined four subcategories for facility operations based on the type of processes performed:

• Subcategory A: Fermentation Operations
• Subcategory B: Biological and Natural Extraction Operations
• Subcategory C: Chemical Synthesis Operations
• Subcategory D: Mixing, Compounding, or Formulating Operations

Additionally, as one the areas leading environmental testing facilities, Teklab, Inc. specializes in providing high-quality Semi-Volatile Organic Compound (SVOC) testing, routinely performing specialty analyses like EPA Method 1671 Particulate Matter Index (PMI) for other environmental testing labs. In addition, we analyze PMI compounds using EPA Methods 1666 and 524.2, ensuring precision and reliability in each method.

Key Details on EPA Method 1671

• Detection Limits: The sensitivity of Method 1671 is typically influenced by sample interferences rather than the limitations of the instrumentation itself.
• Health and Safety: Although the specific toxicity or carcinogenicity of analytes and reagents in this method has not been fully determined, all compounds should be treated as potential health hazards. Teklab emphasizes safety by ensuring that exposure to these substances is minimized to the lowest achievable levels.

Analytical Flexibility and Technology Advances

To accommodate advances in analytical technology and address sample matrix challenges, analysts are permitted to:

• Utilize alternative concentration and cleanup procedures.
• Implement variations in columns and detectors to improve separation or reduce costs, provided these do not compromise method performance.

However, certain restrictions apply:

• Prohibited Changes: Substitutions such as spectroscopy or immunoassay, which degrade method performance, are not allowed.
• Specificity Requirement: Alternative techniques must meet or exceed the specificity of the prescribed method for the target analytes.

Teklab’s commitment to innovation and stringent adherence to EPA guidelines ensures precise, efficient, and reliable results for environmental testing needs. Contact us today to learn more about our advanced testing capabilities and how we can assist with your analytical requirements.

Links to other helpful documents:

• Method 1671, Revision A: Volatile Organic Compounds Specific to the Pharmaceutical Manufacturing Industry
• Permit Guidance Document: Pharmaceutical Manufacturing Point Source Category (40CFR Part439)
• EPA Guidelines: Analytical Method Guidance for the Pharmaceutical Manufacturing Point Source Category
• Federal Register 40CFR Parts 136 and 439. Pharmaceutical Manufacturing Category. Effluent Limitations Guidelines, Pretreatment Standards and New Source Performance Standards