Testing Services & Studies | RSquare BioLabs

BSL-2 / BSL-3 Cleanroom Suite

Microbiology Testing Studies

Subject Overview: RSquare BioLabs offers BSL-2 and BSL-3 sterile and non-sterile microbiological quality control testing tailored for pharmaceutical preparations, medical devices, water systems, and environmental monitoring. Operating under NABL ISO/IEC 17025:2017 standards, our assays comply with IP, USP, BP, and EP monographs.

Complete Microbiology Testing Capabilities:

• Sterility Testing

Membrane filtration and direct inoculation techniques per USP <71> and IP standards in Class 100 / ISO 5 isolators.

• Microbial Limit Testing (MLT)

TAMC, TYMC, and pathogen absence testing (E. coli, Salmonella, S. aureus, P. aeruginosa) per USP <61>/<62>.

• Bacterial Endotoxin Test (BET)

Kinetic chromogenic, turbidimetric, and gel-clot LAL assays per USP <85> for parenteral drugs and medical devices.

• Bioburden Testing

Quantitative microbial population estimation for raw materials, in-process bulk, and non-sterile devices per ISO 11737-1.

• Environmental Monitoring

Active air sampling, settle plates, surface swabs, and personnel glove monitoring for cleanroom validation (ISO 5, 7, 8).

• Water Testing (PW / WFI)

Microbiological testing of Purified Water and Water for Injection including heterotrophic plate count, TOC, and conductivity.

• Antimicrobial Effectiveness (AET)

Evaluating preservative challenge efficacy in multi-dose pharmaceutical preparations per USP <51>.

• Media Fill Validation

Aseptic process simulations using sterile nutrient media to validate sterile filling lines and compounding operations.

• Preservative Efficacy Testing

Testing preservation effectiveness in cosmetics, topical ointments, syrups, and ophthalmic drops.

Dedicated Microbiology Page Request Microbiology Quote

Quality & Efficacy Assurance

Pharmaceutical Testing Studies

Subject Overview: Comprehensive physical, chemical, potency, and stability profiling for Active Pharmaceutical Ingredients (APIs), excipients, raw materials, and finished formulations under cGMP and ICH conditions.

Full Pharmaceutical Testing Portfolio:

• Raw Material Testing

• Finished Product Testing

• Stability Studies (ICH Conditions)

• Method Development

• Method Validation

• Dissolution Testing

• Impurity Profiling

• Cleaning Validation

• Residual Solvent Analysis

• Nitrosamine Analysis

• Elemental Impurity Testing

• Forced Degradation Studies

Dedicated Pharma Page

Chromatography & Spectroscopy

Analytical Services

Subject Overview: Advanced instrument-based scientific evaluation utilizing state-of-the-art chromatography, mass spectrometry, thermal analysis, and spectroscopic instrumentation.

Analytical Instrumentation & Methods:

• HPLC / UHPLC

• GC / GC-MS

• LC-MS/MS

• ICP-MS

• FTIR Spectroscopy

• UV-Visible Spectroscopy

• TOC Analysis

• Particle Size Analysis

• XRD (X-Ray Diffraction)

• DSC / TGA Thermal Analysis

Dedicated Analytical Page

Animal Health Solutions

Veterinary Product Testing Studies

Subject Overview: Quality control, residue monitoring, potency evaluation, and regulatory testing for veterinary pharmaceuticals, vaccines, feed supplements, and animal health APIs.

Complete Veterinary Testing Services:

• Veterinary Drug Analysis

• Veterinary Vaccine Testing

• Feed & Feed Additive Testing

• Veterinary API Testing

• Veterinary Finished Product Testing

• Residue Analysis

• Stability Studies

• Microbiological Testing

• Heavy Metal Analysis

• Packaging Material Testing

• Regulatory Testing for Veterinary Medicines

Dedicated Veterinary Page

ISO 10993 Compliance

Medical Device Testing Studies

Subject Overview: Comprehensive biological safety, chemical characterization, sterility validation, and physical strength testing for medical devices, implants, and diagnostics in accordance with ISO 10993 and CDSCO guidelines.

1. Chemical & Material Characterization

• Material Identification

• Extractables & Leachables (E&L)

• Chemical Characterization

• Residual Analysis

2. Biological Evaluation (ISO 10993)

• Cytotoxicity Testing

• Sensitization Studies

• Irritation Testing

• Hemocompatibility Testing

• Pyrogen Testing

• Implantation Studies

• Systemic Toxicity Testing

3. Microbiological Testing

• Sterility Testing

• Bioburden Testing

• Endotoxin Testing

• Packaging Sterility Validation

4. Physical & Mechanical Testing

• Tensile Strength & Compression

• Fatigue & Seal Integrity Testing

• Packaging Validation

• Shelf-Life & Stability Studies

Dedicated Medical Device Page

Tissue-Based Models

Ex-vivo Studies

Subject Overview: Translational organotypic and excised viable tissue evaluation providing physiological drug permeation, organ bath contractility, biomaterial integration, and tissue-specific toxicity screening.

Ex-vivo Research Capabilities:

• Tissue-Based Drug Evaluation

• Organ Culture Studies

• Skin Permeation Studies

• Corneal Permeation Studies

• Isolated Organ Pharmacology

• Biomaterial Compatibility Studies

• Tissue Toxicity Assessment

• Pharmacodynamic Evaluation

Cellular Bio-Assays

In-vitro Cell Culture Studies

Subject Overview: High-throughput mammalian, primary, stem cell, and cancer cell line models for cytotoxicity, IC50 determination, gene/protein expression, apoptosis, migration, and drug screening.

In-vitro Cell Culture Portfolio:

• Mammalian Cell Culture

• Primary Cell Culture

• Stem Cell Culture

• Cancer Cell Line Studies

• Cell Viability Assays (MTT/XTT)

• Cell Proliferation Assays

• Cytotoxicity Studies

• Apoptosis Assays

• Migration & Invasion Assays

• Cell Imaging & Fluorescence

• Gene Expression Analysis

• Protein Expression Analysis

• High-Throughput Drug Screening

• Dose Response Studies

CPCSEA Accredited Facility

In-vivo Preclinical Studies

Subject Overview: OECD guideline animal safety evaluations, acute/sub-chronic toxicology, pharmacokinetics (PK/PD), disease efficacy models, and implant performance studies.

Preclinical Animal Study Services:

• Acute Toxicity Studies

• Sub-Acute Toxicity Studies

• Chronic Toxicity Studies

• Pharmacokinetic (PK) Studies

• Pharmacodynamic (PD) Studies

• Bioavailability Studies

• Biodistribution Studies

• Disease Animal Models

• Wound Healing Studies

• Anti-inflammatory Studies

• Anti-diabetic Studies

• Anti-cancer Efficacy Studies

• Implant Safety Evaluation

• Biomaterial Performance Studies

Container & Closure QC

Packaging Material Testing

Subject Overview: Quality evaluation of primary and secondary packaging materials used in pharmaceuticals and medical devices.

• Plastic Testing

• Thickness Measurement

• Hardness Testing

Natural Product Authentication

Herbal & Nutraceutical Testing Studies

Subject Overview: Phytochemical marker quantification, contaminant screening, and standardization of botanical extracts and health supplements.

Herbal & Nutraceutical Testing Items:

• Heavy Metals Analysis (ICP-MS)

• Pesticide Residues Screening

• Aflatoxins & Mycotoxins Assay

• Active Marker Compound Analysis

Testing Services & Study Details