CIRRUS PHARMACEUTICALS: CONTAINER-CLOSURE CHARACTERIZATION

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Cirrus Pharmaceuticals Inc. offers a wide range of Container-Closure characterization services, specifically, extractables and leachables evaluation to support product and device development, and packaging material selection. Services range from preliminary material screening to comprehensive material characterization, extractable and leachable method development and validation, routine and stability testing and compatibility evaluations. E&L studies performed at Cirrus are based on the recommendations of the Product Quality Research Institute's Extractables and Leachables Working Group draft guidance to the FDA. Cirrus works in close cooperation with its customers to develop a customized solution for each project, and the experienced staff at Cirrus has the expertise and knowledge to complete projects successfully and in a timely manner.

EXTRACTABLES AND LEACHABLES SERVICES

• Controlled Extraction Studies
• Extractable Profiling and Identification
• Volatile Organic Compound and Residual Solvent Identification
• Extractables and Leachables Method Development, Validation, and Routine Testing
• Migration Studies
• Trace Organic Analysis

EXTRACTABLES AND LEACHABLES INSTRUMENTATION

Cirrus utilizes state of the art instrumentation and facilities to produce high quality data and submission ready results. The instrumentation at Cirrus ranges from general analytical equipment to specialty equipment such as GC-MS and HPLC-MSⁿ.

• Headspace GC-MS
• GC-MS (FID, TCD)
• GC-FID-TCD
• HPLC-MSn
• HPLC-UV (DAD, Fluorescence, ELSD)
• FTIR (ATR)
• TGA and DSC

DELIVERY DEVICES AND PACKAGING MATERIALS FOR EXTRACTABLES AND LEACHABLES EVALUATION

Cirrus scientists have broad experience with a variety of dosage forms, including parenterals, ophthalmics, transdermals, topicals, and particular expertise in inhalation therapies. Cirrus can assist in development and preparation an appropriate E&L program, considering the route of administration, dosage formulation and container closure system.

• OINDPs (MDIs, DPIs, Nasal Devices, Nebulizer Systems)
• Parenterals (Elastomeric Closures, Syringes, Bioprocess Bags and Tubing)
• Opthalmic Delivery Systems
• Implants and Medical Devices
• Transdermal Systems and Topicals
• Blister Trays and Packaging Foils
• Manufacturing Components

CONTROLLED EXTRACTION STUDIES AND MATERIALS CHARACTERIZATION

Cirrus has the capability to perform controlled extraction studies, utilizing multiple extraction techniques as recommended by PQRI guidelines. Extraction methodologies employed at Cirrus include but are not limited to hot reflux extraction, Soxhlet extraction, and microwave assisted extraction.

EXTRACTABLES AND LEACHABLES METHOD DEVELOPMENT, VALIDATION AND ROUTINE SAMPLE ANALYSIS

The experienced scientists at Cirrus Pharmaceuticals can develop and optimize a wide variety of analytical methods (i.e. HPLC-UV (MS), GC-MS, GC-FID, etc.), for the routine analysis of material extractables and leachables. Optimized methods can then be validated according to ICH guidelines and in full compliance with cGMP requirements.