Capsule Filters
Pharmaco Global’s capsule filters are single-use filtration units designed for the precision demands of pharmaceutical liquid filtration, biologics processing, and sterile manufacturing workflows. Housed in disposable capsule-format units, these systems deliver consistent GMP-compliant performance across laboratory-scale development and full-scale pharmaceutical manufacturing — without compromising sterility assurance or operator safety.
The single-use design eliminates filter housing cleaning validation, reduces cross-contamination risk between batches, and simplifies GMP documentation — a practical advantage in regulated pharmaceutical and biopharmaceutical environments operating under WHO GMP, USFDA, and EU GMP standards. Process fluids pass through a choice of membrane media — depth filters, pleated membranes, or sterilising-grade barriers — selected by application, delivering tight specifications for microbial reduction, particulate removal, and process fluid clarity at every manufacturing scale.
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Frequently Asked Questions
Capsule filters are single-use, self-contained filtration units with a pleated membrane sealed inside a plastic housing with inlet and outlet ports. Used in pharmaceutical manufacturing for sterilising filtration, bioburden reduction, vent filtration, and clarification — eliminating the need for separate housings and cleaning validation between batches.
Pharmaceutical capsule filters are available in 0.1 µm and 0.22 µm for sterilising-grade filtration, 0.45 µm and 1.0 µm for bioburden reduction and clarification, and 0.2 µm hydrophobic PTFE for gas and vent filtration. Pore size selection is dictated by the application and pharmacopoeial or regulatory requirements.
Capsule filters are available in PES (low protein binding, ideal for biologics), PVDF (chemical resistance and steam sterilisability), hydrophobic PTFE (solvents and gas filtration), and nylon (general aqueous and organic applications). Membrane material must be validated for compatibility with the specific pharmaceutical formulation being filtered.
PUPSIT (Pre-Use Post-Sterilisation Integrity Test), required under EU GMP Annex 1 (2022), mandates integrity testing of sterilising-grade capsule filters after sterilisation and before product contact. PUPSIT-capable capsule filter designs support in-line wetting and testing — confirming membrane integrity without breaking the sterile barrier before aseptic filtration begins.
Single-use capsule filters eliminate cleaning validation, CIP/SIP requirements, and cross-contamination risk. They reduce batch changeover time, remove housing-integrity variables, and provide complete traceability via lot-specific Certificates of Quality — making them the preferred format for biologics manufacturing, multi-product facilities, and clinical-phase pharmaceutical production.
Capsule filters are integrity tested using the bubble point method — measuring the pressure at which gas displaces liquid from a wetted membrane — or the forward-flow diffusion test, measuring sub-bubble-point gas diffusion rate. Both tests are performed pre-use and post-use, with results documented and compared against validated manufacturer acceptance criteria.
Small capsule filters (10–200 cm²) process 100 mL to 5 L; larger formats (500–2500 cm²) handle 10–200+ L per filtration run. Actual throughput depends on fluid viscosity, particulate load, and membrane pore size. Manufacturers provide flux data and filter-sizing tools based on filterability studies conducted with the actual process fluid.
GMP-grade capsule filters are supplied with lot-specific Certificates of Quality, USP <87>/<88> Class VI biocompatibility compliance, extractables data, bacterial retention validation summaries, integrity test specifications, and FDA Drug Master File (DMF) references — all required for IND, NDA, BLA, and MAA pharmaceutical regulatory submissions worldwide.
Yes, all our products are designed and sourced to meet international regulatory standards, including GMP, USFDA, EU-GMP, WHO, and other relevant compliance requirements.
Absolutely. Our solutions are engineered for seamless integration with existing systems, ensuring minimal disruption and optimal performance within your current setup.
Yes, our team offers technical consultation to help you choose the most suitable product based on your process requirements, facility design, and compliance needs.
Yes, all our products are aligned with our turnkey execution approach, ensuring compatibility with overall facility design, engineering, and operational requirements.
Yes, we provide customised solutions tailored to your process, capacity, and regulatory requirements to ensure optimal performance and efficiency.
Our products are used across pharmaceutical manufacturing, biotechnology, nutraceuticals, research laboratories, and regulated healthcare environments.
We follow strict quality standards and work with trusted technologies and manufacturing processes to ensure consistent performance, durability, and compliance.
Yes, we offer ongoing technical support to ensure smooth operation, performance optimisation, and long-term reliability of all supplied systems and components.
