Article: Ophthalmology QC Suite

QC package for ophthalmology: eye drops, antiglaucoma agents, antibiotics, sterile solutions, osmolality, pH, particles and preservatives.

Package purpose

QC package for ophthalmology: eye drops, antiglaucoma agents, antibiotics, sterile solutions, osmolality, pH, particles and preservatives.

Utility count: 44. The package is intended for QC laboratories, QA, CSV and LIMS/ELN/MES integration.

Data

Typical flow: instrument or LIMS creates input.csv, the utility performs rule-based checks and returns output.json.

Validation

Each utility is supported by URS/FS and scenarios that can be used for IQ/OQ/PQ preparation.

Licensing

Licensing can be discussed as an as-is legal-entity licence without resale rights, a LIMS/ELN/MES integration module, or a pilot package for a production site/laboratory. Representative contacts are rendered from the portal configuration.

Utilities and checked parameters

#	API / product	Utility	Key checks
1	Aflibercept	`aflibercept`	Aflibercept Quality Checker — Biologic Drug (Recombinant Fusion Protein) (Ph.
2	Antimicrobial Preservative Effectiveness	`antimicrobial preservative effectiveness checker`	Antimicrobial Preservative Effectiveness Checker — Preservative efficacy testing (Ph.
3	Benzalkonium Chloride	`benzalkonium chloride`	Benzalkonium Chloride Quality Checker — Benzalkonium Chloride (Antiseptic, Preservative) (Ph.
4	Betaxolol Hydrochloride	`betaxolol hydrochloride`	Betaxolol Hydrochloride Quality Checker — Betaxolol hydrochloride quality assessment (BP/Ph.
5	Bevacizumab	`bevacizumab`	Bevacizumab Quality Checker — Biologic Drug (Monoclonal Antibody) (Ph.
6	Chlorpromazine	`chlorpromazine`	Chlorpromazine Quality Checker — Chlorpromazine quality assessment (Ph.
7	Ciprofloxacin	`ciprofloxacin`	Ciprofloxacin Quality Checker — Ciprofloxacin quality assessment (BP/Ph.
8	Clarity And Opalescence	`clarity and opalescence checker`	Clarity and Opalescence Checker — Проверка прозрачности и опалесценции (Ph.
9	Cocaine Hydrochloride	`cocaine hydrochloride`	Cocaine Hydrochloride Quality Checker — Cocaine hydrochloride quality assessment (BP/Ph.
10	Coloration	`coloration evaluator`	Coloration Evaluator — Оценка степени окраски растворов (Ph.
11	Dexamethasone	`dexamethasone`	Dexamethasone Quality Checker — Dexamethasone quality assessment (BP/Ph.
12	Dorzolamide Hydrochloride	`dorzolamide hydrochloride`	Dorzolamide Hydrochloride Quality Checker — Dorzolamide hydrochloride quality assessment (Ph.
13	Esomeprazole	`esomeprazole`	Esomeprazole Quality Checker — Esomeprazole quality assessment (Ph.
14	Lansoprazole	`lansoprazole`	Lansoprazole Quality Checker — Lansoprazole quality assessment (Ph.
15	Latanoprost	`latanoprost`	Latanoprost Quality Checker — Latanoprost quality assessment (Ph.
16	Levofloxacin	`levofloxacin`	Levofloxacin Quality Checker — Levofloxacin quality assessment (Ph.
17	Mannitol	`mannitol`	Mannitol Quality Checker — Sugar Alcohol (Ph. Eur., USP) ℹ️ The utility checks assay, sorbitol/glucose, water, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
18	Neomycin Sulfate	`neomycin sulfate`	Neomycin Sulfate Quality Checker — Neomycin sulfate quality assessment (BP/Ph.
19	Ofloxacin	`ofloxacin`	Ofloxacin Quality Checker — Ofloxacin quality assessment (Ph.
20	Ofloxacin Ornidazole	`ofloxacin ornidazole`	Ofloxacin Ornidazole Quality Checker — Combo Antibiotic/Antiprotozoal ℹ️ The utility checks content of both APIs, nitro-impurities, synchronous dissolution.
21	Ophthalmic Solution	`ophthalmic solution`	Ophthalmic Solution Quality Checker — Ophthalmic solution quality assessment (Ph.
22	Osmolality Validator	`osmolality validator`	Osmolality Validator — Osmolality assessment (Ph. Eur. 2.2.35) ℹ️ The utility verifies that solution osmolality complies with European Pharmacopoeia requirements. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ For eye drops: 2…
23	p H	`p hchecker`	pH Checker — pH verification for pharmaceutical solutions (Ph.
24	p H Compliance Validator	`p hcompliance validator`	pH Compliance Validator — Проверка соответствия pH (Ph.
25	Pantoprazole	`pantoprazole`	Pantoprazole Quality Checker — Pantoprazole quality assessment (Ph.
26	Pilocarpine	`pilocarpine`	Pilocarpine Quality Checker — Pilocarpine quality assessment (Ph.
27	Potassium Chloride	`potassium chloride`	Potassium Chloride Quality Checker — Potassium Chloride (Ph.
28	Preservative Efficacy Validator	`preservative efficacy validator`	Preservative Efficacy Validator — Проверка эффективности консервантов (Ph.
29	Rabeprazole Sodium	`rabeprazole sodium`	Rabeprazole Sodium Quality Checker — Rabeprazole sodium quality assessment (Ph.
30	Ranibizumab	`ranibizumab`	Ranibizumab Quality Checker — Biologic Drug (Anti-VEGF Fab fragment) (Ph.
31	Riboflavin	`riboflavin`	Riboflavin Quality Checker — Vitamin B2 (Ph. Eur. 2.8.1) ℹ️ The utility checks assay, specific rotation, UV ratios, impurities (lumiflavin, lumichrome), loss on drying. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ Critical f…
32	Sodium Chloride	`sodium chloride`	Sodium Chloride Quality Checker — Sodium Chloride (Table Salt) (Ph.
33	Staff Dose Tracker	`staff dose tracker`	Staff Dose Tracker — Occupational Dose Monitoring (NRB/ICRP) ℹ️ The utility analyzes individual occupational doses, comparing them with established limits (quarterly and annual) per NRB-99/2009 and ICRP recommendations.
34	Sterility Result	`sterility result evaluator`	Sterility Result Evaluator — Sterility test interpretation (Ph.
35	Tobramycin	`tobramycin`	Tobramycin Quality Checker — Tobramycin quality assessment (BP/Ph.
36	Viscosity Analyzer	`viscosity analyzer`	Viscosity Analyzer — Анализ вязкости (Ph. Eur. 2.2.8–2.2.10, 2.2.49) ℹ️ Утилита проверяет соответствие вязкости требованиям Европейской фармакопеи. ℹ️ Не использует машинное обучение — только правила. Использование: ViscosityAnalyzer.exe →…
37	Zinc Sulfate Monohydrate	`zinc sulfate monohydrate`	Zinc Sulfate Monohydrate Quality Checker — Zinc Sulfate Monohydrate (Ph.
38	Ciprofloxacin Impurity Checker	`ciprofloxacin impurity checker`	Utility description: Ciprofloxacin Impurity Checker Ciprofloxacin Impurity Checker — Ciprofloxacin Impurity Control ℹ️ Utility checks critical quality parameters of ciprofloxacin: • Assay (98.
39	InfraLUM ID Ciprofloxacin	`infra lum id ciprofloxacin`	Utility description: InfraLUM ID Ciprofloxacin InfraLUM ID Ciprofloxacin — Ciprofloxacin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
40	InfraLUM ID Levofloxacin	`infra lum id levofloxacin`	Utility description: InfraLUM ID Levofloxacin InfraLUM ID Levofloxacin — Levofloxacin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
41	Levofloxacin Optical Isomer Checker	`levofloxacin optical isomer checker`	Utility description: Levofloxacin Optical Isomer Checker Levofloxacin Optical Isomer Checker — Control of Levofloxacin Optical Isomerism ℹ️ Utility checks critical chiral purity parameters of levofloxacin: • Content of active S-(-)-isomer (…
42	Osmolality	`osmolality`	Osmolality Quality Checker — Control of Solution Osmolality ℹ️ Utility checks compliance of osmolality with specified limits (USP / Ph.
43	Sterility Test Membrane Filtration	`sterility test membrane filtration`	Sterility Test Membrane Filtration Quality Checker — Sterility Testing (Membrane Filtration Method) ℹ️ Utility checks sterility test results of medicinal products by membrane filtration method according to Ph.
44	Viscosity & Rheology	`viscosity rheology`	Viscosity & Rheology Quality Checker — Control of Viscosity and Rheology ℹ️ Utility assesses rheological parameters of pharmaceutical liquids, gels, and ointments according to USP : • Dynamic Viscosity (cP or mPa·s) — resistance to flow • S…