Pharmaceutical manufacturing process unit

{
  "id": "MLC-T-ENV-020830",
  "term": "Pharmaceutical manufacturing process unit",
  "field": "Environment",
  "term_source": "Pharmaceutical Manufacturing Process Unit",
  "definition": "1. Process, as defined in this subpart, and any associated storage tanks, equipment identified in § 63.1252(f), and components such as pumps, compressors, agitators, pressure relief devices, sampling connection systems, open-ended valves or lines, valves, connectors, and instrumentation systems that are used in the manufacturing of a pharmaceutical product.\n\n2. All equipment which collectively function to produce a pharmaceutical product or isolated intermediate (which is also a pharmaceutical product). A process may consist of one or more unit operations. For the purposes of this subpart, process includes any, all, or a combination of reaction, recovery, separation, purification, or other activity, operation, manufacture, or treatment which are used to produce a pharmaceutical product or isolated intermediate. Cleaning operations conducted are considered part of the process. Nondedicated solvent recovery operations located within a contiguous area within the affected source are considered single processes. A storage tank that is used to accumulate used solvent from multiple batches of a single process for purposes of solvent recovery does not represent the end of the process. Nondedicated formulation operations occurring within a contiguous area are considered a single process that is used to formulate numerous materials and/or products. Quality assurance and quality control laboratories are not considered part of any process. Ancillary activities are not considered a process or part of any process. Ancillary activities include boilers and incinerators (not used to comply with the provisions of § 63.1253, § 63.1254, or § 63.1256(h)), chillers and refrigeration systems, and other equipment and activities that are not directly involved (i.e., they operate within a closed system and materials are not combined with process fluids) in the processing of raw materials or the manufacturing of a pharmaceutical product.",
  "abbreviation": "PMPU",
  "subject": "Commercial processes",
  "references": [
    "40 CFR 63.1251 (CFR 2013)",
    "40 CFR 63.1251 (CFR 2013"
  ],
  "url": "https://mlchart.com/terminology/environment/pharmaceutical-manufacturing-process-unit/"
}