NABL Accredited GLP (Pharma Injectable QC Scope) Delhi Lab

Sub-Visible Particulate Matter Testing

Liquid Particle Counter Testing — USP 788 | NABL Accredited Lab | Auriga Research

NABL-accredited sub-visible particle testing per USP 788 (injectables), USP 787 (biotechnology products), and USP 789 (ophthalmic preparations) — three separate pharmacopoeial workflows with different acceptance limits, plus WFI and ISO 14644 cleanroom monitoring. Particle Measuring System operated at our Delhi flagship lab.

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What We Test

Six confirmed liquid particle counter application areas. USP 788, USP 787, and USP 789 are described as three separate pharmacopoeial tests, each with its own scope and acceptance limits.

Injectable Pharmaceutical Products — USP 788

Sub-visible particle testing per USP 788 (light obscuration plus microscopic referee method). LVP no more than 25 particles/mL at 10 micrometers and 3 particles/mL at 25 micrometers; SVP no more than 6000 particles/container at 10 micrometers and 600 at 25 micrometers.

Biotechnology Products — USP 787

Sub-visible particle testing for protein-based biologics per USP 787. USP 787 has different acceptance limits and applicability than USP 788 — lower sample volume, protein aggregate considerations — and is described as a separate test.

Ophthalmic Preparations — USP 789

Particulate matter testing for ophthalmic solutions and suspensions per USP 789 — a third separate test with its own scope and acceptance limits distinct from USP 788 and USP 787.

Water for Injection — USP / IP

WFI particle count monitoring for pharmaceutical water systems per USP 643, USP 1231, and IP requirements. Supports water system commissioning, performance qualification, and routine GMP monitoring.

Clean Room Monitoring — ISO 14644

Cleanroom particulate environmental monitoring per ISO 14644-1 and ISO 14644-2 supporting pharmaceutical manufacturing GMP qualification, classification, and ongoing monitoring of Grade A/B/C/D environments.

Pharma-Grade Purified Water — USP / EP

Particle screening for Purified Water systems in pharmaceutical and cosmetic manufacturing per USP 643 and EP monographs — detecting biofilm shedding, filter failures, and distribution-loop contamination events.

Three separate tests — not one: USP 788 (injections), USP 787 (biotechnology products), and USP 789 (ophthalmic preparations) have different acceptance limits and applicability. Quotes specify which pharmacopoeial test applies to your product and matrix.

Instrument Specifications

Particle Measuring System (PMS) at the Delhi flagship lab, operating on the USP 788 light obscuration principle with a detection range of 1 to 100 micrometers in the liquid phase.

Particle Measuring System at Delhi HQ

Particle Measuring System (PMS) liquid particle counter operated at the Delhi flagship lab supporting injectable pharmaceutical QC and water system monitoring workflows.

Light Obscuration per USP 788

Light obscuration methodology per USP 788. The collimated light beam detects each particle by the proportional reduction in transmitted light intensity, sizing and counting particles in real time.

Detection Range 1 to 100 Micrometers

Detection range of 1 to 100 micrometers in the liquid phase — covering the sub-visible particulate window relevant to USP 788, USP 787, and USP 789.

USP 788 Thresholds — 10 and 25 Micrometers

Reported counts at the >=10 micrometer and >=25 micrometer particle thresholds specified in USP 788 for both large-volume and small-volume parenterals.

Validated for USP 787 and USP 789

Method validated for USP 787 biotechnology product testing and USP 789 ophthalmic preparation testing — separate workflows with separate acceptance criteria from USP 788 injectables.

Make and Model — To Be Confirmed

Specific instrument make and model to be confirmed with the lab team before publishing. Calibration traceable to certified polystyrene latex (PSL) sphere standards.

Liquid Particle Counter instrument at Auriga Research

Industries Served

Three industries served by liquid particle counter testing — pharmaceuticals, medical devices, and pharma-grade water systems.

Pharmaceuticals

Injectables, parenterals, and lyophilised reconstituted products requiring sub-visible particle testing per USP 788, USP 787, and USP 789.

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Medical Devices

Device-grade water systems and fluid pathway testing for medical devices contacting parenteral and ophthalmic dose forms.

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Water Testing

WFI, Purified Water, and pharma-grade water particle count monitoring per USP 643 and IP requirements supporting GMP water system QC.

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Why Auriga for Particle Counting

Three reasons pharmaceutical, biotech, and ophthalmic clients use the Auriga liquid particle counter service.

USP 788, 787, and 789 All Covered

Single lab for injectables (USP 788), biotechnology products (USP 787), and ophthalmic preparations (USP 789) — three separate pharmacopoeial workflows under one accredited roof.

GLP-Compliant Data

GLP-compliant data generation for regulatory submissions — raw data, instrument logs, and validation records aligned with CDSCO and USFDA expectations.

NABL Accreditation Accepted Globally

NABL-accredited results accepted for CDSCO submissions, USFDA dossiers, EU regulatory packages, and CDSCO-recognised international filings.

Related Analytical Technologies

Liquid particle counting pairs with these complementary techniques across the Auriga analytical platform.

FTIR

For particle identification — once sub-visible particles are isolated, FTIR identifies their composition (rubber, silicone, polymer, glass, protein aggregate) for root-cause investigation.

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HPLC

For drug substance quantification, related substances, and assay testing supporting full injectable QC alongside particulate testing per USP 788.

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Get a Quote for Particle Counter Testing

USP 788, USP 787, and USP 789 covered as three separate tests with their own acceptance limits. WFI and ISO 14644 cleanroom monitoring included. Particle Measuring System operated at Delhi HQ.

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