MicroCosmos Imaging Systems · Cosmo-PMT

Particulate Matter Test System for USP 788 & USP 789 in India

Q: Can Cosmo-PMT be adapted to my existing microscope?

A manual Cosmo-PMT setup can be adapted to almost any model or make of microscope, including Zeiss, Nikon, Leica and Olympus. The fully automated version, with a motorized XY/Z stage and joystick navigation, can be adapted to selected models of these microscope brands — our team will confirm compatibility with your specific model before quoting.

Cosmo-PMT is a 21 CFR Part 11 compliant membrane microscope particle counting system for the Microscopic Particle Count Test. It automates filter-paper scanning across multiple fields, classifies particles at ≥10 µm, ≥25 µm and ≥50 µm, and generates a non-editable, audit-ready report per container for LVP, SVP and ophthalmic products.

USP 788 / USP 789 25 mm & 47 mm filters ≥10 / ≥25 / ≥50 µm 21 CFR Part 11 compliant

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Cosmo-PMT motorised particulate matter test microscope

Cosmo-PMT · Multiple-field automated scan

≥10 / ≥25 / ≥50 µmAutomatic classification into all three USP size bands

25 mm & 47 mmFilter paper diameters supported, fully auto-scanned

21 CFR Part 11Electronic records, e-signatures & complete audit trails

LVP + SVPLarge volume & small volume parenteral results, per mL / per container

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Find the Right Cosmo-PMT Configuration for Your Product

Share your product type — LVP, SVP or ophthalmic — and testing requirements. Our specialists will recommend the right configuration, provide pricing, and arrange a demo.

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Cosmo-PMT is a 21 CFR Part 11 compliant particulate matter test system that automates the Microscopic Particle Count Test for USP 788 and USP 789. It auto-scans 25 mm and 47 mm membrane filters, classifies particles at ≥10 µm, ≥25 µm and ≥50 µm, and generates non-editable, audit-ready reports for LVP, SVP and ophthalmic products.

Cosmo-PMT quick specifications
Compendial methods	USP 788, 789, 790, 901
Referenced standards	ISO 8871, ISO 16232, ISO 4406
Size classification	≥10 µm, ≥25 µm and ≥50 µm bands, cumulative counting
Filter paper supported	25 mm and 47 mm diameter membrane filters
Regulatory compliance	21 CFR Part 11 — electronic records, e-signatures, audit trails
Result formats	Count on paper and count per mL / per container — LVP, SVP and ophthalmic
Camera	Cosmo-Captor, made in Germany — 5 MP USB 2.0 standard; 10 MP / 12 MP USB 3.0 options
Compatible microscopes	Any make/model (manual); Zeiss, Nikon, Leica, Olympus and others (motorized)

Every Particle Matters

The membrane microscope method, automated end to end

Particulate matter — also referred to as foreign matter or extraneous matter depending on the compendium — cannot always be measured by light obscuration. For products that cannot be tested that way, the compendia permit a Microscopic Particle Count Test (Method 2) instead. Cosmo-PMT is MicroCosmos’ dedicated instrument for exactly this test.

Instead of an analyst manually scanning a filter under a reticule, Cosmo-PMT drives a motorized XY stage with joystick XYZ navigation to auto-scan the entire membrane filter — 25 mm or 47 mm diameter — across multiple fields, then applies the relevant compendial method settings to count, size and classify every particle.

Results are generated as a non-editable, human-readable report — count on paper and count per mL / per container, split by size band — with the full IQ, OQ and PQ qualification documentation and 21 CFR Part 11 electronic records needed for regulated release testing.

Cosmo-PMT scanned filter paper with particle count graph

Standards and related systems

Cosmo-PMT’s method settings map directly onto the compendial chapters and ISO standards laboratories are tested against, while the rest of the MicroCosmos portfolio supports adjacent particle and imaging workflows.

Technical review

Mangesh Ulhare

Technical Head, MicroCosmos Imaging Systems Pvt Ltd

This page has been technically reviewed for product accuracy, USP 788/789 workflow relevance, and 21 CFR Part 11 compliance descriptions for laboratory buyers in India.

Standards & compendia covered

Built to the standards your product actually needs to meet

Cosmo-PMT’s method settings map directly onto the compendial chapters and ISO standards labs are tested against — no separate instrument needed per standard.

USP 788

Particulate Matter in Injections — large and small volume parenteral products.

USP 789

Particulate Matter in Ophthalmic Solutions.

USP 790

Visible Particulates in Injections.

USP 901

General method reference for particle-related testing.

ISO 8871

Elastomeric and parenteral component testing.

ISO 16232

Cleanliness of components — particulate contamination assessment.

ISO 4406

Hydraulic fluid cleanliness — particle count coding system.

How Cosmo-PMT works

One dedicated method, two compendial chapters, three size bands

Cosmo-PMT is configured out of the box with the acquisition, classification and reporting workflow the Microscopic Particle Count Test requires.

Acquisition & measurement

Scan, count, size, classify

Acquisition and batch run across filter papers
Measurement — count, size parameters and shape parameters
Method setting — dedicated method as per USP 788 and USP 789
Classification — automatic distribution into >10 µm, >25 µm and >50 µm size bands
Complete auto-scanned coverage across multiple fields per filter

Reporting & compliance

Report, sign, archive

Report generation — non-editable, human-readable report templates
Results expressed as count on paper and count per mL / per container
Large volume and small volume parenteral result formats
Auto calibration and verification of the optical system
21 CFR Part 11 compliance across acquisition, analysis and reporting

Particulate matter testing

Built for audit-ready particulate matter release testing

Dedicated compendial test method

A pre-configured method setting applies the required size thresholds automatically — no manual reticule counting or operator-to-operator variability.

Automatic >10, >25 and >50 micron classification

Every detected particle is sized and bucketed into three size bands, with cumulative totals reported the way regulated labs expect.

Complete multiple-field filter scanning

The motorized XY stage and joystick XYZ navigation auto-scan the full 25 mm or 47 mm membrane filter, field by field, so no region is missed.

Results per mL and per container

Cosmo-PMT reports both the raw count on the filter paper and the calculated particle count per mL / per container — suited to large volume and small volume parenterals.

Auto calibration & verification

System calibration with NPL-traceable standards and a standard particle slide keeps every result verifiable and defensible.

Non-editable, human-readable reports

Locked report templates capture equipment, magnification, calibration factor, operator, method and batch details for full traceability.

Cosmo-PMT

Check pricing and availability for the Cosmo-PMT particulate matter test system — our team replies within one business day.

Compendial methodsUSP 788 · 789 · 790 · 901

Referenced standardsISO 8871 · 16232 · 4406

Size classification>10 / >25 / >50 µm

Filter paper25 mm & 47 mm

Compliance21 CFR Part 11

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Motorized particulate matter test system

Filter paper scan — 25 mm and 47 mm membranes

Complete filter scanning and analysis as per USP 788 and USP 789, with 21 CFR Part 11 compliance, qualification documentation, and digital archiving of the scanned membrane at higher magnification. Can be adapted to any existing microscope — Zeiss, Nikon, Leica, Olympus and others.

Motorized particulate matter testing system with XY scanning stage

System overview

Complete filter paper scanning, 21 CFR Part 11 compliant
Qualification documentation — IQ, OQ and PQ
Dedicated method as per USP 788 and USP 789
Digitally archived scanned membrane at higher magnification
Adaptable to existing Zeiss, Nikon, Leica or Olympus microscopes

Scanned filter paper 25 mm and 47 mm membrane Cosmo-PMT

Filter paper scan — 25 mm & 47 mm

Microscope with motorized XY scanning stage; motorized focusing (Z)
Joystick for XYZ navigation across the membrane filter
Stage control, image acquisition and analysis software complying with 21 CFR Part 11
Software module — Cosmo-PMT

Non-editable, human-readable reporting

What a Cosmo-PMT particulate matter test report looks like

Every run captures equipment, magnification, calibration factor, operator and method details alongside the scanned filter image and the size-banded particle counts — locked into a report template that cannot be altered after generation.

Particulate Matter Test Report Generated by Cosmo-PMT · MicroCosmos Imaging Systems

Report IDAuto-generated, unique per run

EquipmentMicroscope model & ID

Magnificatione.g. 100X

Date & TimeTime-stamped automatically

Calibration FactorFrom latest system calibration

Tested ByLogged-in operator

Customer NameAs entered for the batch

Verified BySecond signatory / QA

Test MethodUSP 788 / 789

Sample IDSample / batch reference

No. of FieldsComplete auto-scanned

Quality of LiquidSample volume tested (mL)

Batch No.Product batch number

Paper Size47 mm diameter (or 25 mm)

Cosmo-PMT report scanned filter paper with particle count graph

Actual Particle Count on Filter Paper
Size [µm]	≥10 µm	≥25 µm	≥50 µm	Total
Count	704	216	98	704

Particle Count per mL
Size [µm]	≥10 µm	≥25 µm	≥50 µm	Total
Count / mL	70.40	21.60	3.80	70.40

Sample report data shown for illustration only. USP size-band counts are cumulative — the ≥10 µm figure already includes all particles ≥25 µm and ≥50 µm, which is why it also carries the “Total” column, matching standard compendial reporting convention.

Cosmo-Captor

Camera and system calibration

Cosmo-Captor — camera, made in Germany

Resolution — 5 MP, USB 2.0, 1/2.5" CMOS
Pixel size — 2.2 × 2.2 micron
Software — image grabbing and annotation module as per 21 CFR Part 11
Other camera options — 10 MP USB 3.0; 12 MP USB 3.0

System calibration and validation

Calibration of the system with NPL traceability
Standard particle slide for result validation
Auto calibration and verification built into the Cosmo-PMT workflow

21 CFR Part 11 compliant

Electronic records, signatures and full audit trails

Electronic records

Secure, structured digital records for every particulate matter test run.

Electronic signatures

Signed, non-repudiable approvals built into the reporting workflow.

Secure data storage

Protected storage for raw data, scanned filter images and reports.

Audit trails

Complete, tamper-evident log of every action and edit attempt.

User authentication & login controls

Role-based login restricts access to authorized users only.

Auto backup, restore & versioning

Automated backup routines and full version history protect against data loss.

Applications

Where labs put Cosmo-PMT to work

Large volume parenterals

Particulate matter release testing for LVP infusions as per USP 788.

Small volume parenterals

Microscopic particle count testing for SVP injectable products.

Ophthalmic solutions

Dedicated USP 789 workflow for eye-drop and ophthalmic formulations.

Biologics & high-viscosity products

Serves formulations unsuitable for light obscuration — emulsions, colloids and liposomal preparations.

Medical device components

Particulate testing referencing ISO 8871 for elastomeric and parenteral components.

QC & batch release

Routine batch release and stability testing for sterile fluid manufacturers.

Frequently asked questions

Common questions about Cosmo-PMT and particulate matter testing

What is Cosmo-PMT?

Cosmo-PMT is MicroCosmos’ particulate matter test system — a motorized stage microscope and software platform built to run the Microscopic Particle Count Test described in USP 788 and USP 789. It auto-scans membrane filters, classifies particles into ≥10 µm, ≥25 µm and ≥50 µm bands, and generates a 21 CFR Part 11 compliant, non-editable report.

What is the difference between USP 788 and USP 789?

USP 788 Particulate Matter in Injections applies to most small- and large-volume parenteral products, evaluating particles ≥10 µm and ≥25 µm. USP 789 Particulate Matter in Ophthalmic Solutions applies specifically to ophthalmic products and additionally evaluates particles ≥50 µm. Cosmo-PMT includes a dedicated method setting for both chapters.

When is the Microscopic Particle Count Test used instead of light obscuration?

Method 2 is used when a product cannot be reliably tested by light obscuration — for example emulsions, colloids, liposomal preparations, highly viscous formulations, or products that generate bubbles when drawn through a light-obscuration sensor. Cosmo-PMT automates this membrane microscopy method.

What filter paper sizes does Cosmo-PMT support?

Cosmo-PMT scans both 25 mm and 47 mm diameter membrane filters, with complete, auto-scanned coverage across multiple fields per filter.

How does Cosmo-PMT classify particle sizes?

Every particle detected during a scan is automatically sized and distributed into >10 µm, >25 µm and >50 µm classification bands, consistent with compendial reporting requirements.

Is Cosmo-PMT 21 CFR Part 11 compliant?

Yes. Cosmo-PMT is built for 21 CFR Part 11 compliance — electronic records and signatures, complete audit trails, user authentication and role-based login controls, versioning, auto backup and restore, and secure, tamper-evident data storage.

What does a Cosmo-PMT report include?

Each non-editable, human-readable report includes report ID, equipment and magnification, date and time, calibration factor, tested-by and verified-by fields, test method, sample ID, batch number, number of fields scanned, sample volume, filter paper size, the scanned filter image, and particle counts on paper and per mL / per container by size band.

Can Cosmo-PMT be adapted to my existing microscope?

Manual configuration: a manual Cosmo-PMT setup can be adapted to almost any model or make of microscope, including Zeiss, Nikon, Leica and Olympus.

Motorized configuration: the fully automated version, with a motorized XY/Z stage and joystick navigation, can be adapted to selected models of these microscope brands — our team will confirm compatibility with your specific model before quoting.

Every Particle Matters

Audit-ready particulate, foreign and extraneous matter testing, automated from filter scan to signed report.

Share your product type and testing requirements — our specialists will recommend the right configuration, provide pricing, and arrange a demo.

Call +91 94 04 888 222 Chat on WhatsApp Download Brochure (PDF)

Office402, Brand Square, Kunjir Chowk, Pimple Saudagar, Pune – 411027

Phone+91 94 04 888 222

Emailmangesh@microcosmos.in

ManufacturerMicroCosmos Imaging Systems Pvt Ltd

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