Product Description
Pharmaceutical manufacturing presents the most exacting combination of requirements in the FIBC market. A bulk bag used in pharmaceutical API processing or intermediate transfer must simultaneously satisfy: electrostatic safety in ATEX-classified areas, material purity standards compatible with GMP and drug substance regulations, contamination control protocols for cleanroom-adjacent environments, and full traceability documentation for pharmaceutical quality systems.
Our Type C FIBC Bags for Pharmaceutical Powders are engineered to meet all four requirements in a single bag. Manufactured from 100% virgin conductive polypropylene in a dedicated hygienic production zone, certified to IEC 61340-4-4 for electrostatic grounding performance, and supplied with the GMP-compatible documentation package pharmaceutical quality teams require — these bags deliver the electrostatic safety of Type C with the material integrity demanded by pharmaceutical manufacturing.
Standard Type C vs Pharmaceutical Type C — Key Differences
| Requirement | Standard Type C Bag | Pharmaceutical Type C Bag |
| Electrostatic protection | IEC 61340-4-4 certified | IEC 61340-4-4 certified (same) |
| Material purity | Standard PP (may contain recycled) | 100% virgin PP — no recycled content |
| Production environment | Standard industrial zone | Dedicated hygienic zone |
| Food/pharma contact | Not specified | FDA 21 CFR / EC 10/2011 material compliant |
| Documentation | Test report + COA | Full GMP-compatible documentation package |
| Traceability | Batch record | Full lot traceability + COC + material COA |
Why Choose This Bag?
- 100% virgin conductive PP — no recycled content that could introduce contamination or variability in conductivity performance
- Produced in a dedicated hygienic zone with contamination-control protocols compatible with GMP manufacturing environments
- IEC 61340-4-4 certified grounding resistance < 10⁷ ohm — documented for ATEX risk assessment and pharmaceutical safety files
- Full GMP-compatible documentation package: COC, material COA, FDA 21 CFR compliance declaration, batch traceability records
- Optional pharmaceutical-grade conductive L1 liner for complete inner-surface static control on high-value API contact surfaces
| ⚠️ SAFETY REQUIREMENT: Type C FIBC bag Pharmaceutical MUST be grounded to a verified earth point during ALL filling and discharge operations in pharmaceutical ATEX suites. Verify grounding resistance < 10⁷ ohm before each batch. Consult your ATEX risk assessment to confirm Type C is the correct classification for your specific API and suite classification. |
Typical Applications Industries
- Active Pharmaceutical Ingredients (APIs) with low Minimum Ignition Energy in ATEX-classified suites
- Pharmaceutical excipients processed in areas with solvent vapour presence: lactose, MCC, starches
- Drug intermediates transferred between ATEX Zone 1 process areas
- Nutraceutical and vitamin powders manufactured in classified environments
- Cosmetic active ingredient powders in ISO-classified cleanroom-adjacent environments
| 💡 BUYER TIP: Submit your pharmaceutical supplier qualification questionnaire to us before placing your first order — we maintain a pre-prepared response package that covers all standard pharma SQQ requirements, which typically reduces the qualification timeline from weeks to days. |
Technical Specifications
| Type Classification | Type C (IEC 61340-4-4) |
| Grounding Resistance | < 10⁷ ohm — test certificate per batch |
| Material | 100% Virgin conductive PP — no recycled content |
| Production Environment | Dedicated hygienic zone; contamination controls |
| Food/Pharma Compliance | FDA 21 CFR; EC No. 10/2011 material compliance |
| Construction Options | Circular (preferred for pharma) / U-Panel / 4-Panel |
| Safe Working Load | 500 kg – 1,500 kg (typical pharmaceutical range) |
| Safety Factor | 5:1 (single-use, standard in pharma) |
| Seams | Dust-proof (sift-proof) seams — standard for pharma use |
| Top Options | Spout top with drawstring tie (cleanroom compatible) |
| Bottom Options | Discharge spout with drawstring seal / Conical discharge |
| Liner | Optional pharmaceutical-grade conductive L1 liner |
| Printing | Batch number, product name, grounding instruction; lot traceability codes |
| Documentation | IEC 61340-4-4 test report; COC; material COA; FDA declaration; batch traceability |
| Certification | ISO 21898; IEC 61340-4-4; SGS tested; GMP-compatible documentation |
Frequently Asked Questions
Q1: Does virgin PP conductive fabric perform differently from standard conductive PP?
From an electrostatic performance perspective, both virgin and blended conductive PP fabrics meet the IEC 61340-4-4 resistance requirement of < 10⁷ ohm when properly manufactured. The difference is in material purity and traceability. Virgin PP provides a documented, single-source material without the variability in contamination or conductivity that can arise from recycled content. For pharmaceutical quality systems that require material COA and contamination risk assessment, virgin PP is the only auditable choice.
Q2: Can these bags be used in ISO 7 or ISO 8 cleanroom-adjacent environments?
Our Type C FIBC bag pharmaceutical are produced in a dedicated hygienic zone and can be supplied individually bagged in PE film for cleanroom delivery. They are not manufactured in a classified cleanroom themselves, but their production environment and material standards are compatible with introduction into cleanroom-adjacent ATEX filling suites. If your facility requires bags delivered in a specific cleanliness state, discuss your requirements with our team, and we will advise on the appropriate packaging and documentation.
Q3: Is single-use or multi-trip specification recommended for pharmaceutical APIs?
The pharmaceutical industry standard is single-use (5:1 safety factor) for API and drug substance applications, primarily because multi-trip bags introduce cross-contamination risk between batches that is difficult to validate under GMP. If your process requires multi-trip use for a non-drug-substance application, specify 6:1 safety factor and implement a documented bag inspection and cleaning validation protocol.
Q4: What documentation does our QA department need for supplier qualification?
For pharmaceutical supplier qualification, we provide: IEC 61340-4-4 electrostatic test report, ISO 21898 structural conformity declaration, Certificate of Conformance (COC) per lot, material Certificate of Analysis (COA) for the conductive PP resin, FDA 21 CFR material compliance declaration, EC No. 10/2011 compliance declaration, REACH and RoHS declarations, batch traceability records, and our ISO 9001 quality management system certificate. Site audit support and questionnaire responses are available on request.
Contact Us
| Qualify Tam Tam Packaging as your Type C FIBC supplier for pharmaceutical applications. Request our full documentation package and SQQ response template today.
→ Request Pharma Type C Documentation |
