| Container Capacity and Dimensions | FIBC dimensions must match the available filling, weighing, storage, and discharge equipment. | 500–2,000 L formats Custom height and base Defined fill ratio | Design qualification based on approved user requirements; dimensional control documented in the product specification. | Improves equipment compatibility, warehouse utilization, and material-flow consistency. | Approved drawing, dimensional inspection report, and incoming-quality specification. |
| Fabric and Inner-Liner Material | Materials should be suitable for contact with the product and controlled for cleanliness, composition, and traceability. | Virgin polypropylene fabric PE or multilayer liner Product-specific thickness | Applicable product-contact requirements may include USP <661.1>, USP <661.2>, EU GMP expectations, and customer material specifications. | Supports contamination control, product protection, and consistent barrier performance. | Material certificates, supplier declarations, lot traceability, and extractables or compatibility data when required. |
| Dust-Tight Construction | Powder handling operations require controlled containment during filling, transport, storage, and discharge. | Closed seams Dust-proof top Bottom spout with cover Gasketed liner connection | Leakage and containment performance should be defined in the user requirement specification and verified by an agreed test method. | Reduces powder loss, operator exposure, housekeeping requirements, and cross-contamination risk. | Seam inspection, liner integrity testing, visual inspection, and documented leak-test results where applicable. |
| Filling and Discharge Configuration | The bag must connect securely to filling heads, isolators, split butterfly valves, mills, or transfer systems. | Top inlet spout Bottom discharge spout Iris closure Conical or flat bottom | Connection dimensions and closure methods are controlled through approved engineering drawings and process qualification. | Improves powder recovery, reduces manual handling, and supports repeatable material transfer. | Fit checks, discharge trials, closure inspection, and process-performance records. |
| Electrostatic Control | Electrostatic risk must be assessed when powders, flammable solvents, combustible dusts, or sensitive materials are handled. | Type C conductive FIBC Type D dissipative FIBC Grounding tabs Conductive yarns | IEC 61340-4-4 provides test methods for electrostatic classification of FIBCs; the selected type must match the site risk assessment. | Helps control electrostatic discharge and supports safer powder-transfer operations. | Electrical resistance or discharge test report, grounding instructions, and inspection of conductive components. |
| Mechanical Strength and Safety Factor | The FIBC must withstand lifting, filling, stacking, transport, and repeated handling without loss of containment. | Rated safe working load Four lifting loops Reinforced seams Baffle construction | ISO 21898 covers flexible intermediate bulk containers for non-dangerous goods; design tests should reflect the intended load and handling cycle. | Reduces handling damage, deformation, material loss, and unplanned disposal. | Top-lift test, seam-strength test, stacking assessment, and batch-release inspection. |
| Cleanliness and Bioburden Control | Packaging cleanliness must be appropriate to the product, manufacturing area, and contamination-control strategy. | Controlled manufacturing area Low-lint materials Double-bagging Gamma-compatible options | Cleaning and microbiological requirements are established through the pharmaceutical quality system and product risk assessment. | Supports controlled introduction of packaging into production and reduces cleaning and rejection risks. | Cleaning certificate, bioburden or particulate data when specified, packaging inspection, and release documentation. |
| Extractables and Leachables Risk | Plastic films, coatings, inks, and additives should be evaluated for potential interaction with the pharmaceutical material. | Material selection Low-additive films Reduced-print areas Product-specific studies | Assessment may be aligned with USP <1663> and USP <1664> principles, together with the product-contact risk assessment. | Supports material compatibility and helps prevent avoidable product-quality investigations. | Supplier composition statement, extractables screening, compatibility assessment, and change-control records. |
| Identification and Traceability | Each packaging unit should be identifiable through receipt, use, storage, and investigation activities. | Lot number Manufacturing date Barcode or QR code Product-contact status | Traceability fields are defined in the approved specification and the pharmaceutical quality-management system. | Accelerates line clearance, inventory control, deviation investigation, and targeted recall activities. | Label approval, barcode verification, batch records, certificate of conformity, and retained samples. |
| Packaging and Shipping Protection | FIBCs should arrive protected from moisture, dust, mechanical damage, and uncontrolled handling. | Polyethylene overbag Pallet configuration Moisture barrier Tamper-evident closure | Shipping configuration is established through transport-risk assessment and approved packaging instructions. | Preserves cleanliness and usability from the OEM facility to the pharmaceutical production site. | Packaging configuration record, pallet inspection, transport simulation where required, and delivery inspection checklist. |
| Documentation and Change Control | Pharmaceutical operations require controlled specifications, reproducible manufacturing, and notification of relevant changes. | Technical agreement Approved drawings Change-notification procedure Sample retention | Documentation should support applicable GMP, supplier-qualification, deviation, CAPA, and change-control processes. | Improves audit readiness, supply continuity, and consistency between development and commercial production. | Quality agreement, certificate of analysis or conformity, audit records, deviation reports, and change-control notices. |
| Process Qualification and Sampling | Critical design features should be evaluated under the actual filling, storage, transfer, and discharge conditions. | Pilot lots Factory acceptance samples Performance trials Defined sampling plans | Qualification scope is determined by the pharmaceutical manufacturer’s quality risk management and validation strategy. | Confirms that the custom FIBC performs reliably before routine procurement and full-scale use. | Design qualification, installation or fit assessment, performance test report, and approved validation protocol. |