Active Pharmaceutical Ingredients
Formulation And Filling
Clarification and Prefiltration
Sterile Liquid Filtration and Bioburden Control
Pharmaceutical Venting and Gas Filtration
We manufacture a range of innovative, high performance, cost effective filters specifically designed for each stage of the pharmaceutical manufacturing process.
Biopharmaceutical production including media preparation, buffer preparation, bioreactor support and cell culture harvesting
Solvent filtration in the production of Active Pharmaceutical Ingredients (APIs)
Formulation and powder blending of the various combined substances, including the active drug, to produce the final medical compound
Packaging sterilisation, including sterile vacuum filtration
Autoclave vent filtration to protect the product from external contamination
Clarification and prefiltration for the removal of solid impurities, undissolved powders and particles, critical to the final quality of the product and to protect equipment further downstream
Bioburden reduction for the reduction in particles or bacteria reaching the final sterilising filtration stage
Sterile venting and sterile gas filtration for pressure equalisation and bacteria barrier during storage
Sterile filtration of the final product
Sterile water-for-injection for diluting and dissolving drugs
Steam filtration for particulate removal during sterilisation of process equipment
Sterile filtration of gas for spargers in fermentation and aeration.
Our polymeric cartridge filters are constructed from FDA-approved materials carrying the CFR 21 number for biological safety and materials of construction meet USP Class VI-121°C plastics. Designed and manufactured for robustness, our sterilising grade polymeric filters are fully validated providing retention of >107 colony forming units per square centimetre of effective filtration area as recommended by PDA Technical Reports 26 and 40.
Our range of metal cartridge filters, cartridge housings and filtration systems are manufactured from a variety of metallic and non-metallic materials and can be surface treated and designed to meet the exacting requirements of the pharmaceutical industry. Coded vessels are supplied to BS5500, PED, ASME VIII U-Stamp and other standards as required.
Our range of validated microfiltration pleated and depth filter cartridges include:
microbial stablisation filters
bioburden reduction filters
Material conformity and validation
The bio-safety of all materials in the manufacture of our cartridges is assured by FDA approval and USP Class VI testing.
Our membrane cartridges have been tested and shown to be 100% retentive in line with HIMA, PDA and ASTM F838-05 guidelines for Brevundimonas diminuta challenge (0.2 micron grade). To guarantee the bacterial retention performance of every cartridge, non-destructive integrity testing is performed on each individual module prior to release. A comprehensive validation guide for our cartridges is available on request.
Our dedicated test, development and laboratory services underpin our design and development activity, from filtration media and material characterisation, product verification testing to customer systems simulation trials and in service performance evaluation. Our technical support service capabilities include:
Filter integrity testing,contaminant identification, filterability testing, filter and media efficiency testing, dirt holding capacity testing, filter failure analysis, compatibility investigation, flow versus pressure drop measurements, particle counting.
Comprehensive validation of filters for pharmaceutical processes to the recommendations of the Parenteral Drug Association (PDA):
Process specific validation
Microbial challenge tests
Endotoxin and particulate testing
Customer plant surveys, process filter optimisation, trouble-shooting, pre-inspection review.
Training (held at customer site or at Porvair's technical facilities)
Integrity testing, methods for optimising filtration trains.
In the pharmaceutical industry, various filtration systems are used to separate, purify, and filter pharmaceuticals, raw materials, and various fluids used in the pharmaceutical processes. These systems play a critical role in ensuring the quality, safety, and purity of pharmaceutical products. The choice of filtration system depends on specific pharmaceutical applications and requirements, such as particle size, flow rate, purity, sterilization needs, and more. Pharmaceutical companies need to adhere to international pharmacopoeias and regulatory requirements to ensure that their filtration processes comply with quality standards and regulations. Additionally, the validation and monitoring of filtration systems are essential for ensuring product quality.
1. Serum Filtration Recommended Products:
(1) Respirators: Polytetrafluoroethylene filter cartridges.
(2) Clarification filters: High-precision polypropylene filter cartridges.
(3) Prefiltration: High-precision fiberglass filter cartridges.
(4) Sterilization filtration: High-precision polyether sulfone filter cartridges.
2. Eye Drops Filtration:
(1) Clarification filters: High-precision polypropylene filter cartridges.
(2) Sterilization filtration: Polyether sulfone filter cartridges, double-layer polyether sulfone membrane filter cartridges.
(3) Respirators: Polytetrafluoroethylene air sterilization filter cartridges.
3. Antibiotic Filtration:
(2) Sterilization filtration: Polyether sulfone filter cartridges.
(3) Tank vent respirators: Polytetrafluoroethylene air sterilization filter cartridges.
(4) Decolorization and chlorine removal filtration: Activated carbon fiber filter cartridges.
4. Fermentation Air Filtration:
(1) Prefiltration: Glass fiber gas filter cartridges.
(2) Steam filtration: Polytetrafluoroethylene sintered filter cartridges, stainless steel sintered filter cartridges.
(3) Sterilization filtration: Polytetrafluoroethylene air sterilization filter cartridges.
5. Formulation Filtration:
(1) High-precision polypropylene filter cartridges, polyether sulfone filter cartridges, high-life polyether sulfone filter cartridges, hydrophilic polytetrafluoroethylene sterilization filter cartridges.
6. Cleanroom Ventilation Filtration: