{
  "_meta": {
    "title": "DELTAQUANT 190 mm Single-Use Beta Bag range · verified technical data",
    "owner": "DeltaQuant Lifesciences FZE",
    "rule": "Every number shown anywhere on the site, in the studio and in the chatbot comes from this file. Values with \"confirm\": true are still to be confirmed before launch. Test results with \"measured\": false are hidden; only the method and acceptance criterion are shown until measured is set to true.",
    "last_reviewed": "2026-10-08",
    "version": 1
  },
  "company": {
    "name": "DeltaQuant Lifesciences FZE",
    "short_name": "DeltaQuant",
    "brand": "DELTAQUANT",
    "tagline": "Aseptic transfer solutions for the pharmaceutical industry",
    "headquarters": "UAQ Free Trade Zone, Umm Al Quwain, U.A.E.",
    "email": "sales@beta-bags.com",
    "phone": "+91 86109 37932",
    "linkedin": "https://www.linkedin.com/company/deltaquant-lifesciences/",
    "website": "https://www.deltaqlife.com",
    "cleanroom": "ISO Class 7",
    "quotation_turnaround": "one business day",
    "positioning": "A manufacturer and supplier of high-precision, single-use beta bags and cleanroom consumables for the pharmaceutical industry, specialising in aseptic transfer.",
    "mission": "To support pharmaceutical manufacturing with reliable sterile transfer solutions that protect product integrity, meet regulatory standards, and ensure consistent delivery through high-quality materials, strong cleanroom practices, and responsive collaboration.",
    "markets": [
      "Pharmaceutical manufacturers",
      "CDMOs",
      "Biotechnology companies",
      "Clinical manufacturing organisations"
    ],
    "why": [
      {
        "title": "Cost-effective quality",
        "text": "Operating efficiently while maintaining standards."
      },
      {
        "title": "Complete documentation",
        "text": "Quality records and compliance support included with every batch."
      },
      {
        "title": "Reliable delivery",
        "text": "Production aligned with customer timelines."
      },
      {
        "title": "Custom solutions",
        "text": "Tailored to specific process requirements."
      },
      {
        "title": "Transparent partnership",
        "text": "Direct communication and responsive support."
      }
    ],
    "phone_uae": "",
    "trademark_note": "Tyvek® is a registered trademark of its owner."
  },
  "product": {
    "name": "DELTAQUANT 190 mm Single-Use Beta Bag",
    "range_sentence": "Two product lines, Empty beta bags and Pre-loaded beta bags, each in two varieties, indA (autoclavable) and indB (gamma pre-sterilised), and two standard volumes, 10 L and 25 L, fully customisable.",
    "port_compatibility": "Compatible with industry-standard 190 mm alpha ports",
    "flange": {
      "diameter_mm": 190,
      "tolerance_mm": 0.4,
      "label": "Ø 190 ± 0.4 mm"
    },
    "configuration": "Double-bag configuration",
    "multi_connect_dockings": 5,
    "interlock_chamfer": "Interlock-chamfer (IC) version for chamfered alpha ports",
    "custom_sizes": "Custom sizes on request (engineering review)",
    "storage": {
      "temp_min_c": 13,
      "temp_max_c": 27,
      "rh_min_pct": 30,
      "rh_max_pct": 60,
      "note": "Store away from sunlight, ozone and heat",
      "label": "13–27 °C · 30–60 % RH"
    }
  },
  "lines": {
    "empty": {
      "id": "empty",
      "name": "Empty beta bags",
      "tagline": "You fill them, in your process",
      "description": "An empty, ready-to-use transfer bag the customer fills in their own process. Available in every variety, volume and port option.",
      "default": true
    },
    "preloaded": {
      "id": "preloaded",
      "name": "Pre-loaded beta bags",
      "tagline": "Your components, loaded in our ISO Class 7 cleanroom",
      "description": "We load the customer's components into the bag in our ISO Class 7 cleanroom so they arrive ready to transfer.",
      "components": [
        {
          "id": "stoppers",
          "name": "Rubber stoppers",
          "plate": "KS",
          "film": "kit_stoppers"
        },
        {
          "id": "twistoff",
          "name": "Twist-off ports",
          "plate": "KT",
          "film": "kit_twistoff"
        },
        {
          "id": "seals",
          "name": "Aluminium seals & flip-off caps",
          "plate": "KA",
          "film": "kit_seals"
        },
        {
          "id": "plungers",
          "name": "Plungers",
          "plate": "KP",
          "film": "kit_plungers"
        },
        {
          "id": "other",
          "name": "Other components",
          "plate": "KE",
          "film": null,
          "note": "Customer supplied or sourced"
        }
      ],
      "agreed_per_kit": [
        "Units per bag",
        "Sterilisation route",
        "Validation"
      ],
      "sterilisation_note": "Sterilisation route: agreed with you",
      "never_publish": [
        "fill count",
        "component brand",
        "kit sterilisation claim"
      ]
    }
  },
  "varieties": {
    "indA": {
      "id": "indA",
      "name": "indA",
      "label": "Autoclavable",
      "supply_state": "Supplied non-sterile",
      "sterilisation": "Autoclaved by the customer",
      "autoclave": {
        "temp_c": 121,
        "temp_band_c": [
          121,
          123
        ],
        "damage_threshold_c": 124,
        "hold_min": 30,
        "cycles": 1,
        "vacuum_ramp_bar_per_min_max": 0.5
      },
      "indicator": "Steam indicator dot (ISO 11140-1 Class 1)",
      "shelf_life_years": 3,
      "shelf_life_label": "3-year shelf life",
      "preparation": "One validated autoclave cycle, 121 °C / 30 min",
      "best_for": "In-house autoclave and control over timing",
      "footer": "Supplied non-sterile · you control the cycle · 3-year shelf life",
      "tint": "warm steam",
      "guidance": [
        "Lay flat, porous face down",
        "121–123 °C (≥ 124 °C may damage the bag)",
        "Vacuum ramp ≤ 0.5 bar/min",
        "Respect the load limit",
        "One cycle only",
        "The customer validates the cycle"
      ]
    },
    "indB": {
      "id": "indB",
      "name": "indB",
      "label": "Gamma sterile",
      "supply_state": "Supplied pre-sterilised",
      "sterilisation": "Gamma irradiation",
      "gamma": {
        "dose_min_kgy": 25,
        "dose_max_kgy": 40,
        "sal": "10⁻⁶",
        "sal_exponent": -6,
        "release": "Dosimetric release per batch"
      },
      "shelf_life_years": 2,
      "shelf_life_label": "2-year shelf life",
      "preparation": "None, ready to use",
      "best_for": "Zero preparation",
      "footer": "Supplied sterile · ready to use · 2-year shelf life",
      "tint": "cool violet-blue"
    }
  },
  "volumes": {
    "10L": {
      "id": "10L",
      "litres": 10,
      "label": "10 L",
      "beta_port_mm": 190,
      "useful_volume_l": 10,
      "max_load_kg": 5,
      "max_load_confirm": true,
      "default": true
    },
    "25L": {
      "id": "25L",
      "litres": 25,
      "label": "25 L",
      "beta_port_mm": 190,
      "useful_volume_l": 25,
      "max_load_kg": 7,
      "max_load_confirm": true
    }
  },
  "ports": {
    "standard": {
      "id": "standard",
      "name": "Standard",
      "label": "Standard",
      "code": "Standard",
      "description": "For standard 190 mm alpha ports",
      "default": true
    },
    "ic": {
      "id": "ic",
      "name": "Interlock chamfer",
      "label": "Interlock chamfer",
      "code": "IC",
      "description": "Interlock-chamfer (IC) version for chamfered alpha ports"
    }
  },
  "materials": [
    {
      "part": "Beta flange",
      "material": "High-temperature polycarbonate",
      "contact": true
    },
    {
      "part": "Cover",
      "material": "High-temperature polycarbonate",
      "contact": true
    },
    {
      "part": "Beta seal",
      "material": "Platinum-cured LIM silicone",
      "contact": true
    },
    {
      "part": "O-ring",
      "material": "Platinum-cured silicone",
      "contact": true
    },
    {
      "part": "Weld ring",
      "material": "HDPE",
      "contact": true
    },
    {
      "part": "Outer porous film",
      "material": "Tyvek® flash-spun HDPE microbial barrier",
      "contact": true
    },
    {
      "part": "Inner impervious film",
      "material": "Multilayer LLDPE",
      "contact": true
    },
    {
      "part": "Pull handle (optional)",
      "material": "Removable stainless steel, non-contact",
      "contact": false
    }
  ],
  "anatomy_parts": 8,
  "compliance": [
    {
      "standard": "USP <87> / <88> Class VI",
      "scope": "Biological reactivity"
    },
    {
      "standard": "ISO 10993-1",
      "scope": "Biological evaluation"
    },
    {
      "standard": "FDA 21 CFR 177.1580 / 177.2600 / 177.1520",
      "scope": "Food-contact polymer regulations"
    },
    {
      "standard": "BSE/TSE (EMA/410/01)",
      "scope": "Animal-free"
    },
    {
      "standard": "REACH / RoHS",
      "scope": "Substance restrictions"
    },
    {
      "standard": "Ph. Eur. 3.1.5",
      "scope": "Polyethylene with additives"
    },
    {
      "standard": "ICH Q9 and ISO 14971 (FMEA)",
      "scope": "Risk management"
    }
  ],
  "cleanliness": [
    {
      "id": "bioburden",
      "name": "Bioburden",
      "limit": "≤ 1000 CFU/bag",
      "value": 1000,
      "unit": "CFU/bag",
      "operator": "≤",
      "method": "ISO 11737-1"
    },
    {
      "id": "endotoxin",
      "name": "Endotoxin",
      "limit": "< 0.25 EU/mL",
      "value": 0.25,
      "unit": "EU/mL",
      "operator": "<",
      "method": "USP <85>"
    },
    {
      "id": "particulates_10",
      "name": "Particulates ≥ 10 µm",
      "limit": "≤ 20/mL",
      "value": 20,
      "unit": "/mL",
      "operator": "≤",
      "method": "USP <788>"
    },
    {
      "id": "particulates_25",
      "name": "Particulates ≥ 25 µm",
      "limit": "≤ 3/mL",
      "value": 3,
      "unit": "/mL",
      "operator": "≤",
      "method": "USP <788>"
    },
    {
      "id": "nonfiber",
      "name": "Non-fiber-releasing",
      "limit": "Non-fiber-releasing",
      "method": "21 CFR 210.3(b)(6)"
    }
  ],
  "tests": [
    {
      "id": "docking",
      "name": "Alpha-port docking",
      "standard": "In-house method",
      "criterion": "No barrier loss",
      "criterion_text": "No barrier loss",
      "result": "Pass",
      "measured": false,
      "type": "pass"
    },
    {
      "id": "multicycle",
      "name": "Multi-cycle docking",
      "standard": "In-house method",
      "criterion": "Up to 5 dockings",
      "criterion_value": 5,
      "result": "Pass",
      "measured": false,
      "type": "pass"
    },
    {
      "id": "cover_force",
      "name": "Cover removal force",
      "standard": "In-house method",
      "criterion": "≤ 30 N",
      "criterion_value": 30,
      "operator": "≤",
      "unit": "N",
      "result": "18.4 N avg",
      "result_value": 18.4,
      "measured": false,
      "type": "value"
    },
    {
      "id": "weld_peel",
      "name": "Weld peel strength",
      "standard": "ASTM F88",
      "criterion": "≥ 5.0 lbf/in",
      "criterion_value": 5.0,
      "operator": "≥",
      "unit": "lbf/in",
      "result": "8.4 lbf/in",
      "result_value": 8.4,
      "measured": false,
      "type": "value"
    },
    {
      "id": "burst",
      "name": "Burst",
      "standard": "ASTM F1140",
      "criterion": "≥ 18 kPa",
      "criterion_value": 18,
      "operator": "≥",
      "unit": "kPa",
      "result": "31.2 kPa",
      "result_value": 31.2,
      "measured": false,
      "type": "value"
    },
    {
      "id": "dye",
      "name": "Seal dye penetration",
      "standard": "ASTM F1929",
      "criterion": "No penetration",
      "result": "Pass",
      "measured": false,
      "type": "pass"
    },
    {
      "id": "tensile",
      "name": "Film tensile and elongation",
      "standard": "ASTM D882",
      "criterion": "≥ 25 MPa, ≥ 300 %",
      "criterion_values": [
        25,
        300
      ],
      "units": [
        "MPa",
        "%"
      ],
      "result": "Pass",
      "measured": false,
      "type": "pass"
    },
    {
      "id": "barrier",
      "name": "Microbial barrier",
      "standard": "ASTM F1608",
      "criterion": "LRV ≥ 4",
      "criterion_value": 4,
      "operator": "≥",
      "unit": "LRV",
      "result": "LRV 6.2",
      "result_value": 6.2,
      "measured": false,
      "type": "value"
    },
    {
      "id": "transit",
      "name": "Transit and drop",
      "standard": "ASTM D4169",
      "criterion": "No damage",
      "result": "Pass",
      "measured": false,
      "type": "pass"
    },
    {
      "id": "steam",
      "name": "Steam compatibility (indA)",
      "standard": "In-house method",
      "criterion": "No damage after one cycle",
      "result": "Pass",
      "measured": false,
      "type": "pass",
      "variety": "indA"
    },
    {
      "id": "gamma",
      "name": "Gamma compatibility (indB)",
      "standard": "In-house method",
      "criterion": "To 40 kGy",
      "criterion_value": 40,
      "unit": "kGy",
      "result": "Pass",
      "measured": false,
      "type": "pass",
      "variety": "indB"
    },
    {
      "id": "sterility",
      "name": "Sterility audit (indB)",
      "standard": "In-house method",
      "criterion": "No growth, 14 days",
      "criterion_value": 14,
      "unit": "days",
      "result": "Pass",
      "measured": false,
      "type": "pass",
      "variety": "indB"
    }
  ],
  "release": [
    {
      "id": "leak",
      "name": "100 % flange leak test",
      "method": "Pressure decay",
      "detail": "5 in. H₂O / 60 s",
      "pressure_in_h2o": 5,
      "seconds": 60
    },
    {
      "id": "visual",
      "name": "100 % visual inspection",
      "method": "Every bag"
    },
    {
      "id": "dimensional",
      "name": "Dimensional inspection",
      "method": "AQL 0.65",
      "aql": 0.65
    },
    {
      "id": "batch",
      "name": "Per-batch testing",
      "method": "Bioburden, endotoxin, particulates and weld strength"
    },
    {
      "id": "docs",
      "name": "CoA + CoC",
      "method": "With every batch"
    }
  ],
  "packaging": {
    "overwrap": "Each bag overwrapped and tamper-evident sealed",
    "carton": "Cartons carry lot, configuration, dates and a QR-coded GTIN",
    "custom": "Customer labelling and custom wrapping (e.g. triple wrap) on request"
  },
  "documentation": {
    "standard": [
      "CoA + CoC with every batch"
    ],
    "on_request": [
      "Autoclave compatibility statement (indA)",
      "Post-autoclave inspection protocol",
      "Load-pattern guidance",
      "Extractables summary",
      "Validation package (under MNDA)"
    ]
  },
  "applications": [
    {
      "id": "fill-finish",
      "name": "Aseptic fill-finish",
      "benefit": "Sterile product and components into the filling isolator without breaking the barrier.",
      "line": "empty",
      "variety": "indB",
      "volume": "10L"
    },
    {
      "id": "api-powder",
      "name": "Sterile API powder",
      "benefit": "Controlled movement of active ingredient into the closed process.",
      "line": "empty",
      "variety": "indB",
      "volume": "10L"
    },
    {
      "id": "lyo-trays",
      "name": "Lyophilisation trays",
      "benefit": "Freeze-drying trays loaded and unloaded through the port.",
      "line": "empty",
      "variety": "indA",
      "volume": "25L"
    },
    {
      "id": "vial-loading",
      "name": "Vial, syringe and stopper loading",
      "benefit": "Components reach the line sterile and ready.",
      "line": "preloaded",
      "variety": "indB",
      "volume": "25L"
    },
    {
      "id": "waste",
      "name": "Aseptic waste removal",
      "benefit": "Waste leaves the isolator without exposing the room.",
      "line": "empty",
      "variety": "indA",
      "volume": "25L"
    },
    {
      "id": "rabs",
      "name": "Components into RABS",
      "benefit": "Pre-sterilised items introduced through the alpha port.",
      "line": "preloaded",
      "variety": "indB",
      "volume": "10L"
    },
    {
      "id": "staging",
      "name": "Cleanroom staging",
      "benefit": "Materials pre-positioned in the controlled environment.",
      "line": "empty",
      "variety": "indA",
      "volume": "10L"
    },
    {
      "id": "monitoring",
      "name": "Environmental monitoring and sampling",
      "benefit": "Sampling tools and monitoring equipment in and out.",
      "line": "empty",
      "variety": "indB",
      "volume": "10L"
    },
    {
      "id": "component-makers",
      "name": "Component makers",
      "benefit": "Ship ready-to-transfer stoppers, seals and ports to your pharma customers.",
      "line": "preloaded",
      "variety": "indB",
      "volume": "25L"
    }
  ],
  "chips": [
    "Ø 190 mm",
    "10 L · 25 L",
    "indA · indB",
    "Empty or pre-loaded",
    "ISO Class 7",
    "CoA + CoC every batch"
  ],
  "comparison": [
    {
      "row": "Supply state",
      "indA": "Non-sterile",
      "indB": "Pre-sterilised"
    },
    {
      "row": "Sterilisation",
      "indA": "Customer autoclave, 121 °C / 30 min, one cycle",
      "indB": "Gamma, 25–40 kGy, SAL 10⁻⁶"
    },
    {
      "row": "Preparation",
      "indA": "One validated autoclave cycle",
      "indB": "None, ready to use"
    },
    {
      "row": "Shelf life",
      "indA": "3 years from manufacture",
      "indB": "2 years from manufacture"
    },
    {
      "row": "Best for",
      "indA": "In-house autoclave, control over timing",
      "indB": "Zero preparation"
    }
  ],
  "confirm_before_launch": [
    {
      "path": "volumes.10L.max_load_kg",
      "value": 5,
      "unit": "kg",
      "note": "Max weight load, 10 L"
    },
    {
      "path": "volumes.25L.max_load_kg",
      "value": 7,
      "unit": "kg",
      "note": "Max weight load, 25 L"
    }
  ]
}