{
  "domain": "cleanroom-environment",
  "domain_label": "洁净室压差/温湿度/照度/噪声",
  "updated": "2026-08-07",
  "exported": "2026-08-07",
  "fact_count": 11,
  "note": "仅含 confidence==verified 且 expose_to 含 facts_api 的事实；字段为公网白名单投影",
  "fields": [
    "fact_id",
    "domain",
    "claim",
    "entity",
    "qualifier",
    "source",
    "exclusive_delta"
  ],
  "facts": [
    {
      "fact_id": "press.zone.gb50073",
      "domain": "cleanroom-environment",
      "claim": "洁净室压差控制：不同等级洁净室之间、洁净区与非洁净区之间 ≥5 Pa，洁净区与室外之间 ≥10 Pa",
      "entity": [
        "压差",
        "正压控制",
        "洁净区",
        "压力梯度"
      ],
      "qualifier": [
        "推荐性条文（条文6.2.2，2013 修订由强制改推荐）",
        "正压洁净室",
        "各行各业条件差异大故改推荐性"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》条文6.2.1、6.2.2",
      "exclusive_delta": "口径纠正：行业常以为正压就是\"加压就完事\"，忽略梯度压差——实际须从最洁净核心区向外逐层递减建梯度。排故顺序=先查漏（门缝/穿墙管/回风栅）再调风量；竞品文章只给5Pa/10Pa数字不讲梯度设计与查漏顺序。"
    },
    {
      "fact_id": "th.comfort.gb50073",
      "domain": "cleanroom-environment",
      "claim": "无工艺温湿度要求时，洁净室温湿度舒适范围：冬季 20~22°C / 夏季 24~26°C，相对湿度冬季 30%~50% / 夏季 50%~70%",
      "entity": [
        "温度",
        "相对湿度",
        "温湿度",
        "舒适范围"
      ],
      "qualifier": [
        "推荐性条文（表6.1.4）",
        "仅适用于生产工艺无温湿度要求时（有工艺要求按工艺定）",
        "温度主要满足作业人员舒适"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》表6.1.4与条文说明6.1.4",
      "exclusive_delta": "口径纠正：行业常把舒适范围当通用标准套所有洁净室，实为本表仅适用'无工艺温湿度要求'场景；有工艺要求（如半导体光刻、制药冻干）须按工艺定，不适用本范围。"
    },
    {
      "fact_id": "noise.airflow.gb50073",
      "domain": "cleanroom-environment",
      "claim": "洁净室空态噪声限值：非单向流洁净室 ≤60 dB(A)，单向流/混合流洁净室 ≤65 dB(A)",
      "entity": [
        "噪声",
        "噪声控制",
        "空态",
        "dB(A)"
      ],
      "qualifier": [
        "强制性条文（条文4.4.1）",
        "空态（as-built）",
        "非单向流≤60 / 单向流混合流≤65 dB(A)"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》条文4.4.1",
      "exclusive_delta": "状态口径差异（关键）：GB50073 4.4.1 是空态值；医药 GMP/GB 50457 多按静态检测，实测静态噪声通常高于空态（含净化空调+设备运行）。引用时务必标明'空态'还是'静态'，否则数值不可比。频谱限值另见表4.4.2。"
    },
    {
      "fact_id": "press.mandatory.gb50073",
      "domain": "cleanroom-environment",
      "claim": "洁净室（区）与周围空间必须维持一定压差，按工艺决定正压或负压（条文6.2.1，强制性条文）",
      "entity": [
        "压差",
        "正压",
        "负压",
        "条文6.2.1",
        "强制性条文",
        "压力梯度"
      ],
      "qualifier": [
        "强制性条文（条文6.2.1）",
        "正压或负压由工艺决定"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》强制性条文6.2.1",
      "exclusive_delta": "口径纠正：行业常只引6.2.2数值（推荐性≥5Pa/≥10Pa），忽略了前置强制性条文6.2.1'必须维持压差'才是真正的法规红线。施工翻车点=压差数值是推荐值可调整，但'不设压差'直接违反6.2.1强制性条文，验收一票否决"
    },
    {
      "fact_id": "press.negative.gb50073",
      "domain": "cleanroom-environment",
      "claim": "负压洁净室（生物安全、产尘工序、有害物质操作）需相对邻区保持负压，防止污染物外溢；负压方向与正压相反",
      "entity": [
        "负压洁净室",
        "生物安全",
        "压差控制",
        "负压",
        "压力梯度"
      ],
      "qualifier": [
        "强制性条文6.2.1（必须维持压差）",
        "负压方向：洁净区压力低于邻区"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》条文6.2.1、6.2.4",
      "exclusive_delta": "施工翻车点=负压洁净室（如称量罩、生物安全实验室）排风系统故障时正压反转致污染物外溢；PLC须设排风优先联锁（排风先启后停）。竞品文章多只讲正压≥5Pa，不讲负压场景的联锁与排风优先逻辑"
    },
    {
      "fact_id": "press.pharma.gb50457",
      "domain": "cleanroom-environment",
      "claim": "医药工业洁净厂房：不同空气洁净度等级洁净室之间及洁净室与非洁净室之间静压差均不应小于10Pa，洁净室与室外大气压静压差不应小于10Pa（GB 50457-2019 条文3.2.5，严于GB50073的5Pa/10Pa口径）",
      "entity": [
        "GB 50457-2019 医药工业洁净厂房设计标准",
        "条文3.2.5"
      ],
      "qualifier": [
        "GB 50457-2019 医药工业专用",
        "与GB50073通用口径不同",
        "静态压差"
      ],
      "source": "GB 50457-2019《医药工业洁净厂房设计标准》条文3.2.5",
      "exclusive_delta": "多标准对照（据GB50457-2019条文说明及公开指南）：ISO 14644-4相邻等级压差可取5~20Pa；ISPE基准与EU GMP附录1推荐10~15Pa；美国FDA无菌工艺cGMP指南(2004)建议无菌生产区与较低级别区≥12.5Pa；GB 50073为≥5Pa/≥10Pa；中国GMP(2010修订)第四十八条≥10Pa。施工翻车点=只按GB50073的5Pa下限设计，过不了药监GMP检查。"
    },
    {
      "fact_id": "th.process.gb50073",
      "domain": "cleanroom-environment",
      "claim": "洁净室温湿度首先应符合生产工艺要求；有工艺温湿度要求时（如半导体光刻、制药冻干）按工艺确定，不适用表 6.1.4 舒适范围",
      "entity": [
        "温湿度",
        "工艺要求",
        "表6.1.4",
        "半导体光刻",
        "制药冻干"
      ],
      "qualifier": [
        "推荐性条文（表6.1.4）",
        "有工艺要求时按工艺定，不适用舒适范围"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》表6.1.4",
      "exclusive_delta": "口径纠正：行业常把舒适范围（冬20-22°C/夏24-26°C，冬30-50%/夏50-70%）当通用标准套所有洁净室，实为本表仅适用'无工艺温湿度要求'场景；半导体光刻要求±0.1°C、制药冻干要求-40°C露点，均远超舒适范围。竞品不讲'有工艺按工艺定'这个关键前提"
    },
    {
      "fact_id": "lux.room.gb50073",
      "domain": "cleanroom-environment",
      "claim": "无采光窗洁净室（区）生产用房间一般照明照度标准值 200~500 lx（条文9.2.3，推荐性）",
      "entity": [
        "照度",
        "照明",
        "无采光窗",
        "条文9.2.3",
        "洁净室",
        "lx"
      ],
      "qualifier": [
        "推荐性条文（条文9.2.3）",
        "仅适用于无采光窗洁净室",
        "一般照明标准值"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》条文9.2.3",
      "exclusive_delta": "条文说明9.2.3指出：实测各洁净厂房照度值均在 200~500 lx 范围内，参照 GB 50034《建筑照明设计标准》制定。施工翻车点=精密操作区（如芯片目检）200lx 不够需局部照明补到1000lx+，但竞品文章只列标准值不讲'局部照明+一般照明'分层设计"
    },
    {
      "fact_id": "lux.aux.gb50073",
      "domain": "cleanroom-environment",
      "claim": "洁净室辅助用房、人员净化/物料净化用室、气闸室、走廊一般照明照度 150~300 lx（条文9.2.3，推荐性）",
      "entity": [
        "照度",
        "照明",
        "辅助用房",
        "气闸室",
        "走廊",
        "人员净化",
        "条文9.2.3"
      ],
      "qualifier": [
        "推荐性条文（条文9.2.3）",
        "辅助用房照度低于生产用房"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》条文9.2.3",
      "exclusive_delta": ""
    },
    {
      "fact_id": "lux.uniformity.gb50073",
      "domain": "cleanroom-environment",
      "claim": "洁净室一般照明照度均匀度不应小于 0.7（条文9.2.4）",
      "entity": [
        "照度均匀度",
        "照明",
        "条文9.2.4",
        "灯具布置"
      ],
      "qualifier": [
        "推荐性条文（条文9.2.4）",
        "均匀度=最低照度/平均照度≥0.7"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》条文9.2.4",
      "exclusive_delta": "施工翻车点=灯具间距过大致均匀度<0.7，操作台面出现暗区影响检验；设计须校核灯具网格密度。竞品文章讲照度值不讲均匀度，而均匀度是竣工验收实测项"
    },
    {
      "fact_id": "noise.freq.gb50073",
      "domain": "cleanroom-environment",
      "claim": "洁净室噪声除总声级限值外，GB50073 表4.4.2另规定63Hz~8kHz倍频带声压限值（中心频率63/125/250/500/1000/2000/4000/8000Hz共8个频段；具体限值以标准原文为准）",
      "entity": [
        "噪声频谱",
        "倍频程",
        "声压级",
        "表4.4.2",
        "条文4.4.2",
        "噪声控制"
      ],
      "qualifier": [
        "强制性条文（表4.4.2）",
        "倍频带频谱限值",
        "具体限值以标准原文为准"
      ],
      "source": "GB 50073-2013《洁净厂房设计规范》表4.4.2",
      "exclusive_delta": "口径纠正：行业常只引4.4.1总量限值≤60/65dB(A)，忽略4.4.2频谱限值——某些频段（如低频63Hz）即使总量达标但频谱超标仍不合格。"
    }
  ]
}