Sartorius Microbiological Testing: Sterility, Bioburden & Air Monitoring

If you run QC in pharmaceuticals or bioprocessing, Sartorius gives you an end-to-end microbiological testing toolkit that covers three critical workflows: sterility testing, bioburden (microbial enumeration), and cleanroom air monitoring. The Sterisart® platform delivers closed-system sterility tests with modern Gen 4 peristaltic pumps; the Microsart® line streamlines colony counting with contact-free membrane transfer; and MD8 air samplers support continuous environmental monitoring in critical areas—all designed for traceability and compliance.

Product Families: Sterisart, Microsart & MD8 Air Samplers

Sterisart® Sterility Testing (Gen 4 + canisters)

• Gen 4 peristaltic pump moves product and media into Sterisart® canisters with contamination-free transfer, audit trails, and paperless reporting (21 CFR Part 11 features on Advanced model). 
  
• Sterisart® NF systems are closed, single-use, gamma-sterile, and validated for membrane-filtration sterility tests—minimizing secondary contamination risk. 
  

Microsart® Enumeration (membrane filtration & media)

• Microsart® @filter integrates funnel, base, and gridded membrane in one sterile unit for reliable colony counting and bioburden testing
• Microsart® @media prefilled agar dishes and e.motion dispenser-ready membranes speed up transfer and incubation while reducing handling.

MD8 Air Monitoring (fixed & portable)

• MD8 Airscan® (fixed) and AirPort MD8 (portable) are designed for microbial air monitoring with gelatin membrane filters or BACTair™ plates, supporting Grade A/critical-zone monitoring and routine trending. 

How to Choose: Samples, Throughput & Compliance

Sample type & workflow:

Sterility release of injectables or media? Choose Sterisart® (closed systems + Gen 4 pump). Regular bioburden for water, raw materials, or intermediates? Use Microsart® membrane filtration with @filter & @media. Cleanroom or isolator monitoring? Select MD8 with gelatin filters or BACTair™ plates.

Throughput & handling risk:

Single-use closed sterility canisters and contact-free membrane transfer lower contamination risk and speed repeatable handling at scale. 

Regulatory alignment:

Routine sterility tests follow USP <71>/Ph. Eur. 2.6.1 (harmonized/ interchangeable across ICH regions). Environmental monitoring is guided by EU-GMP Annex 1 (2022 revision) for viable/non-viable monitoring in sterile manufacture. 

Featured Models & Specifications

Here you’ll find a curated set of representative SKUs across Sterisart® sterility testing, Microsart® bioburden filtration, and MD8 microbial air monitoring—covering the most common QC workflows. The table highlights the specs you actually compare (pore size, flow or sampling rate, materials/compatibility) plus concise compliance notes (e.g., USP <71>, Ph. Eur. 2.6.1, Annex 1 alignment) so you can shortlist by sample type and throughput. Match the core units with the right accessories—Sterisart® canisters, Microsart® @media plates, or gelatin membranes—to fit your SOP. All item numbers are validated against the Sartorius eShop as of August 11, 2025; regional availability can vary, so contact iRight for confirmation, alternates, or QA documentation.

Use Cases: Sterile Release, Bioburden Control & Cleanroom Monitoring

Sterile release of finished products and intermediates

• Run USP/Ph. Eur. membrane-filtration sterility tests with Sterisart® NF canisters and the Gen 4 pump to reduce open handling and improve data integrity.

Routine bioburden / microbial limit testing

• Filter, transfer, and incubate faster using Microsart® @filter + e.motion membranes and prefilled @media plates for consistent colony counts.

Cleanroom & isolator environmental monitoring

• Deploy MD8 Airscan® in fixed positions for routine monitoring; use AirPort MD8 for mobile checks. Pair with gelatin filters or BACTair™ plates to fit your method.

FAQs: Sterility vs Rapid Methods, Annex 1, Workflow & Risk

1. Can rapid methods replace USP <71>/Ph. Eur. 2.6.1?

No. Rapid or screening methods can complement QC decisions, but routine sterility release remains governed by harmonized pharmacopoeial chapters (USP <71> / Ph. Eur. 2.6.1) that are interchangeable under ICH Q4B. 

2. What does Annex 1 expect for viable environmental monitoring?

The 2022 Annex 1 emphasizes robust contamination control strategies and ongoing viable monitoring of Grade A/critical areas as part of sterile manufacturing. Your monitoring plan (fixed + portable samplers, media choice, trending) should reflect risk and process design. 

3. Why choose closed sterility testing or contact-free membrane transfer?

Closed sterility canisters and dispenser-ready membranes reduce open handling, lowering false-positive risk and improving repeatability—especially at higher throughput.

Get a Quote: Talk to iRight for Pricing & Lead Time

Ready to configure your microbiological testing lineup? Contact iRight for model selection, current pricing, lead times, and a downloadable pack of GMP documentation to support your QA review and audits. We’ll help you compare Sterisart®, Microsart®, and MD8 options against your SOPs and regulatory commitments.