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Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. Contaminants that could potentially cross a container closure barrier include microorganisms, reactive gases, and other substances (USP <1207>). Container closure systems should maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life. Container closure systems consist of primary packaging components and secondary packaging components (USP <1207>). Primary packaging components are those components that come into direct contact with the product, such as a glass vial or syringe. While, secondary packaging components are those components that are vital to ensure correct package assembly, such as aluminum caps over stoppers (USP <1207>). Container closure integrity testing can be performed in many different ways. All of the testing methods have pros and cons. In addition, some containers, such as ampoules, require 100% integrity testing. The deterministic methods of container closure integrity testing include: Electrical Conductivity and Capacitance Test (HVLD); Laser-based Gas Headspace Analysis; Mass Extraction; Pressure Decay; Tracer Gas (vacuum mode); Vacuum Decay. Contract Container Integrity Testing laboratories offer numerous state- of-the-art options for leak testing and assessing pharmaceutical package integrity per USP <1207>. Container Closure Integrity test programs have been successfully used to optimize sealing parameters, evaluate container storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages and support regulatory submission applications for product commercialization around the world.

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AMRI

Jubilant HollisterStier

Mithra CDMO

Neopharm Labs Inc

Pace Analytical Services, LLC

Vitas Analytical Services

West pharma services

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Container Closure Integrity

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AMRI's container closure integrity experts provide accurate, sensitive and reliable data for definitive container closure integrity verification, especially for packages that demand the highest degree of product protection.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Assessment Programs

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Container Closure Integrity (CCI) Techniques ...

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West offers various techniques and approaches to address all types of packaging and delivery systems that are compliant with USP <1207>

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Assessment Programs

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Container & Packaging Testing

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Our skilled and competent Chemistry group uses a wide range of methods to test raw materials, FDFs and packaging components in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Assessment Programs

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Container Closure Integrity Testing

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Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Assessment Programs

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Container Closure Integrity Testing

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The microbiological laboratory will provide a range of testing complied with USP and EP requirements.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Assessment Programs

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Container Closure Integrity / Ingress Testing

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Pace Analytical Life Sciences (PLS) is a full-service contract testing laboratory providing physical and functional testing services to the pharmaceutical and medical device industries.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Assessment Programs

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Container Closure Integrity via Microbial Imm...

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Jubilant HollisterStier’s innovative microbiological and analytical labs are operated by experienced professionals using the most current equipment and procedures to ensure seamless technical transfer of analytical methods for our clients.

- Directory Listing

Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Assessment Programs

Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. Contaminants that could potentially cross a container closure barrier include microorganisms, reactive gases, and other substances (USP <1207>). Container closure systems should maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life. Container closure systems consist of primary packaging components and secondary packaging components (USP <1207>). Primary packaging components are those components that come into direct contact with the product, such as a glass vial or syringe. While, secondary packaging components are those components that are vital to ensure correct package assembly, such as aluminum caps over stoppers (USP <1207>). Container closure integrity testing can be performed in many different ways. All of the testing methods have pros and cons. In addition, some containers, such as ampoules, require 100% integrity testing. The deterministic methods of container closure integrity testing include: Electrical Conductivity and Capacitance Test (HVLD); Laser-based Gas Headspace Analysis; Mass Extraction; Pressure Decay; Tracer Gas (vacuum mode); Vacuum Decay. Contract Container Integrity Testing laboratories offer numerous state- of-the-art options for leak testing and assessing pharmaceutical package integrity per USP <1207>. Container Closure Integrity test programs have been successfully used to optimize sealing parameters, evaluate container storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages and support regulatory submission applications for product commercialization around the world.

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