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
- Veterinary medication
- 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:
- clarification filters
- microbial stablisation filters
- sterilising filters
- bioburden reduction filters
- vent filters
- gas filters
- industrial housings
- sanitary housings
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:
Laboratory services
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.
Validation services
Comprehensive validation of filters for pharmaceutical processes to the recommendations of the Parenteral Drug Association (PDA):
- Process specific validation
- Filter compatibility
- Retention studies
- Microbial challenge tests
- Endotoxin and particulate testing
- Extractables testing.
On-site services
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.
Industries