Human plasma-derived albumin 25% aqueous solution, net supplied at plant

1. Scope and Applicability

This is a civil environmental inventory method for a single human plasma-derived albumin aqueous solution supplied at 25 g albumin per 100 mL in the sealed 100 mL single-vial carton presentation, with actual product-specific quality release and net dispatch at the manufacturer gate. The complete wet formulation is the reference object, not dry albumin or a therapeutic service. Albuminar-25 (US label revised June2013) establishes a real documented example; its label is not evidence of current availability everywhere. Do not pool different species, concentrations, routes, brands with incompatible formulations, raw plasma, whole blood, immune sera, immunoglobulins or other final fractions into the denominator.

Use batch/cohort environmental records only; collect no donor personal identifiers. Biological manufacturing units may remain source-grounded black boxes with complete actual material, utility, water, emission and waste exchanges. This document supplies no biological enrichment, pathogen processing, separation/purification or activity-enhancement operating parameters, recipes or laboratory protocols, and no clinical administration or dose. Clinical equivalence and generic blood-unit conversions are outside this reference definition.

2. Product Category Identity

Field	Value
canonical_pcr_id	pcr.other-transportable-goods-except-metal-products-machinery-and-equipment.other-chemical-products-man-made-fibres.human-plasma-derived-albumin-25-percent-solution
classification_refs	CPC3.0 35272; narrow subset context only, no accepted mapping asserted
covered_products	One separately declared human plasma-derived 25% mass/volume albumin aqueous formulation, 100 mL single-vial carton presentation, net supplied at plant
excluded_products	Animal blood/fractions; recombinant albumin; raw human blood/plasma; other albumin strengths; immunoglobulins; clotting factors; antisera; clinical service
representative_product	Albuminar-25, documented 100 mL vial containing 25 g albumin in the complete aqueous formulation; historical US label, not a universal supplier specification
production_route	Human pooled-plasma-derived manufacturing route documented by the original supplier, represented as environmental black boxes including all actual manufacturing and auxiliaries; no operating protocol reproduced
market_state	Quality-released sealed aqueous solution; declare actual full formulation, container, site, dispatch gate and temperature-control history

3. Reference Flow

Field	Value
What	Supply the specified human plasma-derived albumin formulation at plant dispatch gate for downstream environmental modelling
How much	1 kg net supplied complete wet solution, excluding packaging mass
How well	25 g albumin per 100 mL; actual product-specific accepted release, supplied form and batch assay; no efficacy equivalence
How long or cycle	One closed, declared dispatch accounting period and matched product cohort, with opening/closing WIP and finished-goods carry-over
reference_flow_link	finished_solution

Field	Value
Reference amount	1
Reference product flow	blood products 04caea53-a455-4adc-b7d2-3bc102bf7971
Reference flow property	Mass 93a60a56-a3c8-11da-a746-0800200b9a66
Reference unit group	Units of mass 93a60a57-a4c8-11da-a746-0800200c9a66
Reference unit	kg
Required qualifiers	human source; plasma-derived route; 25% mass/volume strength; full supplied formulation; brand and specification; 100 mL vial presentation and actual fill; batch/cohort; quality release; actual net dispatch gate; opening/closing WIP and finished-goods burdens; site and supply geography; temperature history; primary/secondary packaging; allocation-gate products; upstream dataset boundaries

Required qualifiers must be supplied in the concrete data package. Native identity limitations: the full selected name is "blood products; Production mix, at plant"; its comment includes human plasma-derived medicinal products. Geography/location of supply is unspecified, CAS is absent, route and grade fields are empty, and its sole property is reference Mass with factor1. The native CPC35260 label differs from target35272; retain this classification debt for data-owner review. This broad identity supports only a qualified human product exchange; it does not establish the 25% formulation, a manufacturing technology, supplier quantities or a CN/HK/global geography. Restrict this reference to the declared at-plant gate.

4. Measurement and Unit Rules

rule_id	Applies to	Required property	Required unit	Rule
reference_mass	reference product	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	Use net mass of complete supplied wet solution. Q is actual net dispatch, not newly released production P. The finished_solution row is 1 kg per reference flow.
solution_basis	all inventory rows	Mass	kg	Measure mass directly or convert matched batch volume with independently measured density at declared conditions. 25 g/100mL is mass/volume, not 25% mass fraction; no default water fraction or density. Constituent assay and carrier water are subledgers, never additional purchases.
utility_basis	all inventory rows	Measured exchange property	declared row unit	Convert raw units before normalize_dispatch. Rate times duration is allowed for actual rates; integrated liquid/gas volume is not multiplied by time. Use independently documented calorific and temperature/pressure bases.

5. System Boundary

Boundary Abstraction

Field	Value
declared_starting_condition	Traceable human plasma collection and supply, or a purchased plasma dataset with the complete declared upstream burden; no zero-burden donation assumption
starting_condition_role	Actual external human-plasma input; expand collection/testing/cold-chain processes when not already covered upstream
product_classification_scope	One specified human albumin solution only; the CPC leaf is broader than the methodology
recursive_input_rule	A purchased albumin intermediate carries its own complete upstream dataset and exact identity; do not recurse infinitely or apply a zero manufacturing burden
upstream_dataset_requirement	Match human origin, supplied state, route, geography, period, collection/testing, shared-plasma allocation, temperature-controlled transport and boundary coverage; disclose gaps
disclosure	Cradle to actual net plant dispatch; all manufacturing, QC, consumables, utilities, water preparation, packaging, storage, rework, waste treatment and loading included. Customer transport/use is a separate extension. Public black boxes conceal no environmental burden.

Boundary Rules

rule_id	applies_to	rule	source_ids
b_complete	albumin_supply	Inventory every actual material, energy carrier, water stream, disposable, packaging component, co-product, waste and elementary emission as separate atomic exchanges. Extend this initial card set for any additional real exchange; absence requires evidence, not a cut-off. Supplier datasets may carry upstream units but must be boundary checked against foreground meters.	ifc-pharma-biotech-2007
b_thermal	albumin_supply	Retain actual plasma cold-chain collection, transport and storage, manufacturing cooling/heating, clean utilities and final warehousing/handling/loading. The cited final label specifies controlled room temperature, so do not impose a refrigerated final product by default. Record actual temperature-control history, time, site, electricity and refrigerant losses without publishing manufacturing operating parameters.	csl-albuminar25-label-2013; ifc-pharma-biotech-2007
b_gate	albumin_supply	The terminal gate is actual unique net dispatch of accepted complete solution at plant. Newly quality-released mass P is an internal production-to-store transfer, not Q. Keep production, finished-store and dispatch ledgers with internal transfers cancelled in the combined ledger. Closing undelivered finished goods and their carried burdens are excluded from Q and carried forward; opening finished goods retain their prior manufacturing burdens when dispatched.	jrc-ilcd-2010

6. Process Inventory Structure

Process Map

process_id	process_name	inclusion	inclusion_condition	role	quantitative_reference
albumin_supply	Human albumin supply environmental black box	required	All actual units within the declared cradle-to-dispatch boundary; expand upstream units missing from purchased datasets	Single-product reporting over an auditable unallocated multi-product physical ledger	1 kg net supplied wet solution at plant

Process: Albumin supply (albumin_supply)

Inputs

Product flows

Human plasma feedstock (plasma)

Full wet plasma received with collection, testing, collection consumables, upstream allocation and cold-chain burdens. Human source only; no donor identities. Do not duplicate its contained water as another purchase.

• Selected flow: Human plasma feedstock
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_material.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_material
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Ethanol solution (ethanol)

If actually used, record the complete purchased solvent formulation and its assay as a subledger, including fresh make-up, recovery imports/exports and losses. Internal recirculation is not fresh purchase. No operating concentration is prescribed.

• Selected flow: Ethanol solution
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_material.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_material
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Sodium caprylate (caprylate)

Record the actual acquired supplied form if used, including carrier water within that commercial input. Label identity does not supply a recipe or amount.

• Selected flow: Sodium caprylate
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_material.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_material
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Sodium acetyltryptophanate (acetyltryptophanate)

Record actual complete commercial input if used; assay is a constituent subledger.

• Selected flow: Sodium acetyltryptophanate
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_material.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_material
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Sodium bicarbonate (sodium_bicarbonate)

Conditional on actual consumption, not a mandatory formulation ingredient. Preserve purchased form and strength.

• Selected flow: Sodium bicarbonate
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_material.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_material
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Sodium hydroxide solution (sodium_hydroxide)

Conditional actual manufacturing or cleaning input, separate functional destinations in the raw ledger without duplicate procurement.

• Selected flow: Sodium hydroxide solution
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_material.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_material
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Acetic acid solution (acetic_acid)

Conditional actual input; keep full supplied formulation, measured concentration and inventory changes.

• Selected flow: Acetic acid solution
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_material.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_material
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Water for injection (wfi)

Only externally supplied water crosses this product-input boundary. Onsite generation is an internal transfer: retain source water, purification energy, consumables and rejects once in the same expanded black box.

• Selected flow: Water for injection
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_material.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_material
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Process water (water)

Include actual cooling make-up, cleaning and onsite purified-water feed by submeter; no duplicate of external supplied formulations or recirculating cooling water.

• Selected flow: Process water
• Flow property / unit: Volume / m3
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_utilities.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_utilities
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Electricity (electricity)

Include collection/testing facilities, manufacturing black boxes, clean-area HVAC, water preparation, refrigeration, QC, warehouse, rework and loading attributable to the matched cohort.

• Selected flow: Electricity
• Flow property / unit: Energy / kWh
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_utilities.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_utilities
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Purchased steam (steam)

Actual purchased heat only; onsite steam remains an internal transfer with boiler fuel, water and emissions recorded once. Retain condensate and return enthalpy basis.

• Selected flow: Purchased steam
• Flow property / unit: Energy / MJ
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_utilities.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_utilities
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Natural gas (natural_gas)

If actually burned onsite, retain metered gas and documented calorific basis; other actual fuels require separate atomic cards. Purchased steam does not erase onsite fuel burdens.

• Selected flow: Natural gas
• Flow property / unit: Energy / MJ
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_utilities.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_utilities
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

1,1,1,2-Tetrafluoroethane (r134a_makeup)

Only if this is the actual refrigerant. Use charge, recovered mass, maintenance and stock records. Other refrigerants require their own distinct rows; no default refrigeration chemistry is assumed.

• Selected flow: 1,1,1,2-Tetrafluoroethane
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_utilities.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_utilities
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Glass vial (vial)

Record actual primary glass vessel consumption including rejects, breakage and samples; verify supplier composition.

• Selected flow: Glass vial
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_packaging.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_packaging
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Synthetic rubber vial stopper (stopper)

Conditional actual stopper; verify elastomer identity, supplied mass and rejects rather than assuming all closures have one composition.

• Selected flow: Synthetic rubber vial stopper
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_packaging.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_packaging
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Aluminium vial closure (aluminium_cap)

Conditional actual aluminium component; polymer component, if present, requires its own card.

• Selected flow: Aluminium vial closure
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_packaging.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_packaging
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Paperboard carton (carton)

Actual single paperboard package, not a bundle of all packaging. Record leaflets, labels and other actual components separately if present.

• Selected flow: Paperboard carton
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_packaging.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_packaging
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Printed paper leaflet (leaflet)

Actual printed leaflet; include material production and printing with a compatible background dataset.

• Selected flow: Printed paper leaflet
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_packaging.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_packaging
• Sources: csl-albuminar25-label-2013; ifc-pharma-biotech-2007; jrc-ilcd-2010

Polypropylene filter cartridge (filter)

Only if actually consumed; complete disposable item and verified composition. Every other actual filter, tubing, bag, reagent, cleaning chemical or QC consumable must have an additional specific card; none is cut off by this example.

• Selected flow: Polypropylene filter cartridge
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_material.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_material
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Waste flows

Elementary flows

Outputs

Product flows

Net supplied finished solution (finished_solution)

The terminal reference exchange is exclusively the human plasma-derived 25% albumin solution, complete wet formulation, newly net supplied at the manufacturer dispatch gate. Packaging mass is excluded from reference mass but its burdens are included. No other component shares this reference row. Required qualifiers must be supplied in the concrete data package. Native identity limitations: the full selected name is "blood products; Production mix, at plant"; its comment includes human plasma-derived medicinal products. Geography/location of supply is unspecified, CAS is absent, route and grade fields are empty, and its sole property is reference Mass with factor1. The native CPC35260 label differs from target35272; retain this classification debt for data-owner review. This broad identity supports only a qualified human product exchange; it does not establish the 25% formulation, a manufacturing technology, supplier quantities or a CN/HK/global geography. Restrict this reference to the declared at-plant gate. Native comment distinguishes blood-centre whole blood/components and fractionation-centre plasma derivatives from artificially produced blood substitutes. All native name components are retained here: basename blood products, no name-property qualifier, no treatment/standards/route qualifier, production mix at plant. There are no secondary flow properties or density factors. The record establishes neither a donor geography nor clinical product comparability.

• Selected flow: blood products 04caea53-a455-4adc-b7d2-3bc102bf7971
• Flow property / unit: Mass / kg
• Amount rule: 1 kg
• Value mode: fixed_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: method_formula
• Collection protocol: cp_output
• Sources: csl-albuminar25-label-2013; jrc-ilcd-2010

Human plasma-derived immunoglobulin bulk solution (immunoglobulin_coproduct)

Only when actually leaving the expanded black box as a separate co-product in this supplied state. It is not the reference product and has no potency or efficacy equivalence. Every other actual co-product requires a distinct identity and row at its true allocation gate.

• Selected flow: Human plasma-derived immunoglobulin bulk solution
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_allocation.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_allocation
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Waste flows

Rejected human albumin solution (rejected_solution)

Actual discarded formulation, including failed zero-output batches, QC samples, expiry and returned material not recovered. Carry its full incurred manufacturing and disposal burdens; do not subtract it from inputs as avoided production.

• Selected flow: Rejected human albumin solution
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_waste.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_waste
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Human plasma protein residue (plasma_residue)

Actual wet residue; distinguish water, protein and other constituents in subledgers. No handling or pathogen-treatment procedure is provided; record actual treatment provider and burdens.

• Selected flow: Human plasma protein residue
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_waste.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_waste
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Pharmaceutical process wastewater (wastewater)

Meter each actual discharge, retain composition, destination, treatment and sludge linkage. Chemical oxygen demand is a measured indicator, not mass, protein, ethanol or reaction-water inference.

• Selected flow: Pharmaceutical process wastewater
• Flow property / unit: Volume / m3
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_waste.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_waste
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Spent ethanol solution (spent_solvent)

Actual waste solvent exported for treatment; distinguish recovered solvent sold as co-product and internal solvent recirculation.

• Selected flow: Spent ethanol solution
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_waste.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_waste
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Spent polypropylene filter cartridge (used_filter)

Actual used filter with contamination and treatment route separately documented. Other disposable wastes require separate rows.

• Selected flow: Spent polypropylene filter cartridge
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_waste.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_waste
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Waste glass vial (glass_waste)

Broken or rejected glass, with actual contamination and destination; do not give clean-recycling credit to contaminated glass by default.

• Selected flow: Waste glass vial
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_waste.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_waste
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Pharmaceutical wastewater treatment sludge (sludge)

Actual wet sludge and dry-solids subledger; treatment utility burden remains included, with no duplicate external wastewater-treatment inventory.

• Selected flow: Pharmaceutical wastewater treatment sludge
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_waste.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_waste
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Elementary flows

Ethanol, to air (ethanol_air)

Measured or independently substantiated actual ethanol emission after control; preserve medium, time coverage and uncertainty. Not inferred from a generic VOC total without speciation.

• Selected flow: Ethanol, to air
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_emissions.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_emissions
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Carbon dioxide, fossil, to air (co2_air)

Actual onsite fossil combustion emission with documented fuel carbon or compatible factor. Other actual species each require a separate row; upstream provider emissions are not counted again onsite.

• Selected flow: Carbon dioxide, fossil, to air
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_emissions.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_emissions
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

1,1,1,2-Tetrafluoroethane, to air (r134a_air)

Only actual same-refrigerant leakage; reconcile charge, recovery and inventory, independent of energy use.

• Selected flow: 1,1,1,2-Tetrafluoroethane, to air
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_emissions.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_emissions
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

Water vapour, to air (water_vapour)

Independently measured or supported evaporation; do not fit evaporation and unknown reaction-water formation to the same mass residual.

• Selected flow: Water vapour, to air
• Flow property / unit: Mass / kg
• Amount rule: A_j / Q, reported once in this row unit; see the sole reporting operation in section 8; cp_emissions.
• Value mode: calculated_value
• Specificity: site_specific
• Normalization basis: per 1 kg reference flow
• Basis kind: reference_flow
• Evidence kind: calculated_from_collection
• Collection protocol: cp_emissions
• Sources: ifc-pharma-biotech-2007; jrc-ilcd-2010

7. Allocation and Co-product Handling

rule_id	applies_to	rule	source_ids
a_hierarchy	albumin_supply	First separate attributable collection/testing, product-specific manufacturing, QC, packaging, cold storage and handling by physical records. For shared plasma and shared manufacturing, retain every actual co-product and the unallocated physical inventory. Use justified physical causality where demonstrated; otherwise use explicitly justified actual allocation-gate economic values, with same-period quantities/prices and sensitivity against another defensible basis. No universal albumin allocation share, zero-burden donated plasma or automatic clinical-value allocation is supplied.	jrc-ilcd-2010
a_ledger	albumin_supply	Allocate shared burdens only after raw physical closure; product-specific burdens stay with that product. Fractions leaving at different intermediate/final states use values at that exact shared gate, never final retail prices uncorrected for later processing. Allocation shares sum to one for the shared pool. Separate wastes, recirculation and co-products; no double avoided-product credit. Preserve both allocated and unallocated ledgers.	jrc-ilcd-2010

8. Foreground Data Collection, Calculation, and Quality Rules

Data Collection Protocols

The aggregation column states only the final report basis. Every collection_method retains unnormalised raw numerators and inventory/carried burdens. Only normalize_dispatch performs A_j / Q; the card expression and this report-basis label refer to that same operation.

protocol_id	process_id	flow_role	record_type	raw_fields	collection_method	unit	frequency	temporal_coverage	site_scope	aggregation_rule	quality_evidence
cp_output	albumin_supply	Terminal product and inventory gate	foreground_record	Quality and warehouse data owners: product/specification; anonymised batch/cohort; P new release; unique net dispatch receipts Q; returns; mass; density/volume if converted; opening/closing WIP and finished goods; carried burden vectors; destination; acceptance status	Owners retain raw unreduced receipts, weighing and inventory/carried-burden records. Reconcile production-to-store transfers P and store-to-dispatch movements separately, cancel internal transfers; establish Q from accepted unique net supplied wet mass, excluding undelivered stocks, duplicate acceptance and unresolved returns. No division here.	kg	Each batch/event and period close	One matched closed raw reporting period plus traced opening/closing carry-over	Declared collection/supplier/manufacturing and storage sites; no donor personal data	per 1 kg reference flow	Calibrated measurements; invoices; environmental batch ledger; stock reconciliation; full provider boundary and uncertainty
cp_material	albumin_supply	Actual material and consumable exchanges	foreground_record	Manufacturing/environmental data owner: each actual purchased formulation; supplied mass; assay; supplier; receipts; opening/closing raw stock; opening/closing WIP; carried burdens; rejected and zero-output batches; returns/rework; recovery; losses	Reconcile all raw-period actual consumptions and full supplied formulations with invoices, batch environmental records and stocks; constituent assays are subledgers. Include zero-output, rework and QC burdens, upstream collection and testing coverage. No enrichment or manufacturing procedure is recorded. Retain unnormalised numerators only.	kg	Each batch/event and period close	One matched closed raw reporting period plus traced opening/closing carry-over	Declared collection/supplier/manufacturing and storage sites; no donor personal data	per 1 kg reference flow	Calibrated measurements; invoices; environmental batch ledger; stock reconciliation; full provider boundary and uncertainty
cp_utilities	albumin_supply	Energy water and refrigeration	foreground_record	Utilities owner: separate meter readings and unit conversions; carrier; calorific value; rates/duration or integrated volume flag; water source; utility returns; refrigeration service and charge/recovery; site/time; allocation drivers	Collect raw full-period meters including idle/startup, failed batches, water preparation, clean-area services, QC, cold chain and actual finished-store/loading loads. Separate purchased utilities from internal generation; maintain disaggregated units and actual attribution records. No normalisation in collection.	kWh; MJ; m3; kg	Each batch/event and period close	One matched closed raw reporting period plus traced opening/closing carry-over	Declared collection/supplier/manufacturing and storage sites; no donor personal data	per 1 kg reference flow	Calibrated measurements; invoices; environmental batch ledger; stock reconciliation; full provider boundary and uncertainty
cp_packaging	albumin_supply	Packaging consumption	foreground_record	Packaging owner: each material/component; mass per item measured; purchased/used counts; reject/breakage; stock movements; formulation mass excluded from tare	Keep unreduced component totals for the matched cohort, including scrap, tests, rework and returned packaging. Count-to-mass needs actual weighed component mass. Document complete supplier composition; no default pack mass.	kg	Each batch/event and period close	One matched closed raw reporting period plus traced opening/closing carry-over	Declared collection/supplier/manufacturing and storage sites; no donor personal data	per 1 kg reference flow	Calibrated measurements; invoices; environmental batch ledger; stock reconciliation; full provider boundary and uncertainty
cp_waste	albumin_supply	Wastewater and individual wastes	foreground_record	Environmental/waste owner: individual stream; wet mass/volume; independently measured composition/density; treatment destination; off-spec/expiry; sludge; recovery; inventory and provider coverage	Retain complete raw transfers, sampling and treatment manifests for each waste with its actual handling burden. Reconcile mass, water and constituents without COD-to-mass inference. Include failed/zero-output and return disposal; avoid double treatment with provider datasets. No treatment operations protocol is supplied.	kg; m3	Each batch/event and period close	One matched closed raw reporting period plus traced opening/closing carry-over	Declared collection/supplier/manufacturing and storage sites; no donor personal data	per 1 kg reference flow	Calibrated measurements; invoices; environmental batch ledger; stock reconciliation; full provider boundary and uncertainty
cp_emissions	albumin_supply	Individual elementary exchanges	foreground_record	Environmental owner: species; medium; actual measured mass or independently supported factor inputs; control boundary; time; uncertainty; water balance; fuel carbon; refrigerant balance	Keep raw species-specific monitoring or factor calculations before division, including control and cold-chain losses. Total VOC, COD and closure residuals cannot identify an unknown species. Separate reaction-water evidence from independent physical mass/element closure; never solve two unknowns from one residual.	kg	Each batch/event and period close	One matched closed raw reporting period plus traced opening/closing carry-over	Declared collection/supplier/manufacturing and storage sites; no donor personal data	per 1 kg reference flow	Calibrated measurements; invoices; environmental batch ledger; stock reconciliation; full provider boundary and uncertainty
cp_allocation	albumin_supply	Shared burdens and co-products	foreground_record	LCI accounting owner: all actual co-products; exact shared gate and state; raw physical outputs; causal driver; same-period quantities and gate prices; allocated/unallocated burdens; WIP/finished inventory carry vectors	Collect underlying records without division by Q. Preserve actual co-product states and the complete common burden pool, then apply the disclosed a_hierarchy decision and trace inventory/carried burdens to the same final supplied cohort. Record actual driver and price uncertainty.	kg; declared currency	Each batch/event and period close	One matched closed raw reporting period plus traced opening/closing carry-over	Declared collection/supplier/manufacturing and storage sites; no donor personal data	per 1 kg reference flow	Calibrated measurements; invoices; environmental batch ledger; stock reconciliation; full provider boundary and uncertainty

Calculation Rules

rule_id	Applies to	Formula or rule	Inputs	Output	source_ids
carry_dispatch	all inventory rows	For each exchange/burden j, retain A_j = raw-period attributable burden + opening WIP burden + opening finished-goods burden - closing WIP burden - closing finished-goods burden, with same-product/route/state cohort tracking and explicit returned-material reversal/carry adjustments. This is burden matching, not raw physical output accounting. Keep product-specific and allocated shared burdens identifiable; cancel internal transfers and do not divide here.	raw_period_burdens; opening_wip_burdens; closing_wip_burdens; opening_finished_burdens; closing_finished_burdens; return_adjustments; cp_output; cp_allocation	A_j	jrc-ilcd-2010
normalize_dispatch	all inventory rows	x_j = A_j / Q. Q is the positive unique accepted net dispatched wet-solution mass at the selected plant gate in kg. This is the sole reporting division after raw conversions and carry_dispatch; flow-card amount and protocol aggregation are references to this same operation, not extra divisions. No numeric dataset can be reported when Q is zero, negative or unresolved.	A_j; Q; cp_output; cp_material; cp_utilities; cp_packaging; cp_waste; cp_emissions; cp_allocation	x_j	jrc-ilcd-2010
physical_closure	albumin_supply	Reconcile complete raw physical inputs plus opening raw/WIP/finished stocks against unique dispatched solution, actual co-products, other actual external Product outlets and utility returns, wastes/emissions and closing raw/WIP/finished stocks before allocation. Keep a separate complete physical packaging ledger, including packaging carried out with dispatched goods, rejects and opening/closing packaging stocks; packaging mass remains outside solution Q. Use only actual physical masses in each applicable balance and cancel internal transfers between material, utility and packaging ledgers once. P production release is an internal transfer and is cancelled, never added again as external output. Measure total wet mass, water and independently supported protein/solvent/element balances; reaction water and actual species require independent evidence. Do not fit unknown water and another unknown outlet to a residual.	cp_output; cp_material; cp_utilities; cp_packaging; cp_waste; cp_emissions; cp_allocation	unallocated_physical_ledger	ifc-pharma-biotech-2007; jrc-ilcd-2010

Data Quality Requirements

requirement_id	Applies to	Requirement	Evidence
q_identity	reference product	Match human origin, exact formulation/strength, full wet supplied state and plant gate; native family UUID alone cannot define any of these qualifiers. Site and supply geography must be measured, not inferred from the native blank geography or historical label.	Original supplier specification and anonymised batch release/dispatch records
q_complete	all inventory rows	Retain complete actual black-box manufacturing, upstream collection/testing, energy/water, packaging, QC, storage/loading, failure and rework burdens. Never claim packaging-only records cover manufacturing. Ordinary auxiliary UUID/provider matching is disclosed separately from final-reference identity.	Complete material/utility/waste ledger and upstream coverage matrix
q_inventory	all inventory rows	Opening stocks carry prior burdens, closing undelivered stocks carry burdens forward. Returns remain linked to original batch/dispatch; reverse prior dispatch and burdens when required, carry subsequent rework/storage, and count final net supplied mass once. Reacceptance does not create new production or a second delivery.	Separate production, store and dispatch reconciliations with transaction linkage and burden vectors

9. Validation Rules

rule_id	applies_to	rule	source_ids
v_reference	finished_solution	Require one terminal Product output finished_solution, 1 kg complete wet solution, with the declared UUID and at-plant gate in both languages. Other real intermediates/co-products stay separate; no renaming or UUID hiding to imply another reference. No efficacy or generic blood-unit conversion.	csl-albuminar25-label-2013
v_period	albumin_supply	Require positive Q, matched full raw period/cohort, complete failed/zero-output and rework burdens, physical closure and opening/closing WIP/finished-goods carry-over. Prove one normalize_dispatch division only. Do not equate P release with Q dispatch or include undelivered finished stock in Q.	jrc-ilcd-2010
v_inventory	all inventory rows	Every actually present exchange must be represented atomically with complete native restrictions where selected, compatible provider boundaries, real amounts/units and a protocol owner. Missing material burdens, unresolved physical closure, unsupported species or omitted carry-over prevent a complete foreground dataset; unknowns cannot be zero-filled.	ifc-pharma-biotech-2007; jrc-ilcd-2010

10. Published Dataset Profile

Field	Value
dataset_role	secondary_dataset; background_dataset
downstream_use	Environmental modelling of the exactly specified human albumin solution supplied at plant
allowed_use	Matched formulation, human source, strength, route, site, gate and period with complete upstream and carry-over accounting
excluded_use	Clinical dosing, therapeutic equivalence, generic blood units, other species/fractions, recombinant route or packaging-only representation of manufacture
required_metadata	Product formulation and assay; original supply specification; period; site/geography; plant dispatch gate; Q and P distinction; upstream boundary; allocation; temperatures; all actual protocols and provider identities
required_quality_disclosure	Uncertainty, sampling, exclusions, native broad-identity/classification limits, auxiliary UUID/provider gaps, zero-output/rework and inventory carry-over; no methodology approval implied
update_trigger	Change in human source, formulation/strength, route, site, supply state, temperature chain, provider boundary, allocation, reference gate or inventory method

11. Data Sources

source_id	type	reference	used_for
csl-albuminar25-label-2013	official_guidance	CSL Behring, Albuminar-25 prescribing information, revised June2013; https://labeling.cslbehring.com/pi/us/albuminar25/en/albuminar25-prescribing-information.pdf ; retrieved 2026-10-16	Original manufacturer label pp1-2: human plasma origin, 25 g/100mL aqueous supplied state, vial presentations and controlled-room-temperature storage. Historical US example only; no current-market guarantee, global-site assumption, environmental factor, recipe, clinical use or efficacy conversion.
ifc-pharma-biotech-2007	official_guidance	World Bank Group/IFC, EHS Guidelines Pharmaceuticals and Biotechnology Manufacturing, 30April2007, pp4-5,12,19-20; https://www.ifc.org/content/dam/ifc/doc/2000/2007-pharma-biotech-ehs-guidelines-en.pdf ; retrieved/reverified 2026-10-16	Sector environmental boundary: actual wastewater, waste, clean utilities, water preparation and monitoring. General applicability only; no product-specific yield, emission factor, operating parameter or mandatory chemical recipe.
jrc-ilcd-2010	handbook	European Commission JRC, ILCD Handbook General guide Detailed guidance, first edition March2010, section7.9, PDF pp275-277,283-284; https://eplca.jrc.ec.europa.eu/uploads/ILCD-Handbook-General-guide-for-LCA-DETAILED-GUIDANCE-12March2010-ISBN-fin-v1.0-EN.pdf ; retrieved/reverified 2026-10-16	Attributional subdivision, physical causality and justified exact-gate economic allocation. PCR-specific raw-period, return and carry-over rules operationalise mass/burden consistency; no blood-specific fixed share, clinical value or physiological burden factor is derived.