BIOIntegrity


BIOIntegrity Inc. is Western Canada's premier distributor and manufacturer’s representative of ultra-pure fluid handling products and single-use systems. With over 20 years of industry experience, they partner with reputable bioprocess product manufacturers to offer innovative, high-quality, and cost-efficient solutions for bioprocessing challenges across various industries including biotech, pharmaceutical, cannabis, nutraceutical, food, beverage, chemical, and cosmetic sectors. Their philosophy emphasizes integrity, quality, innovation, and long-term relationships with clients.

Industries

biotechnology
clinical-trials
training

Nr. of Employees

small (1-50)

BIOIntegrity

Edmonton, Alberta, Canada, North America


Products

Single-use mixing and biocontainer systems

Single-use biocontainers, mixing containers and associated transfer and mixing assemblies for aseptic single-use processing and storage.

Single-use and cartridge filtration assemblies

Capsule and cartridge filtration products and configurable single-use filter assemblies for clarification, sterile filtration and scale-up deployment.

Tangential flow and hollow-fiber ultrafiltration devices

Tangential flow filtration and hollow-fiber ultrafiltration devices in capsule and cartridge formats suitable for autoclave, SIP or gamma sterilization.

High-purity tubing, hoses and sanitary fittings

Platinum-cured silicone, TPE, PTFE, FEP, EPDM and other high-purity tubing and hygienic hose assemblies with sanitary fittings and custom manifolds.

316L stainless sanitary housings and components

Sanitary filter housings, T-type housings and fittings manufactured from 316L stainless steel, electropolished with controlled surface finish for hygienic processing.

Hygienic and low-shear pumps

Range of hygienic pumps including diaphragm and centrifugal designs suitable for sanitary transfer of process fluids and biologics.

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Services

Regulatory, CMC and Quality Consulting

Consulting services covering regulatory strategy, CMC, quality management systems, compliance with GMP/GLP/GCP/GPP/MDSAP, and regulatory affairs for multiple international agencies.

Process Engineering and Project Management

Facility master planning, process design, equipment integration, modular facility design and project development for vaccine, biologics, API and aseptic manufacturing operations.

Filter Performance and Analytical Testing

Filterability testing, extractables analysis, particle retention efficiency testing, qualitative and quantitative chemical analysis, and filter compatibility screening.

Validation and Microbiological Services

Microbial retention studies, product-based integrity testing, compatibility screening, extractables testing and preparation of GMP validation documentation.

SEM and X-Ray Materials Analysis

Scanning electron microscopy and X-ray analysis with low vacuum imaging for component and materials analysis.

Facility Audits and Technical Tours

Formal audits and inspections of manufacturing, laboratory and quality operations; hosting facility tours for customers.

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Expertise Areas

  • Bioprocessing and single-use systems
  • Filtration and purification (including TFF/UF)
  • Process engineering and facility design
  • Regulatory compliance and CMC consulting
  • Show More (4)

Key Technologies

  • Single-use systems and biocontainers
  • Tangential flow filtration (TFF)
  • Hollow-fiber ultrafiltration (UF)
  • Sterilizing membrane filters
  • Show More (10)

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