INSIGHTS ON PHARMACEUTICAL INSPECTION
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![ASM 2000 Bucket]( "A High Sensitivity Solution For Pharma CCIT")
A High Sensitivity Solution For Pharma CCITExperience a comprehensive CCIT solution completely adapted to the needs of pharma customers. The software features intuitive menus, simple navigation, 21 CFR part 11 compliance, traceability, and data storage.
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![Xray Feature]( "Effects Of X-Ray Inspection On Pharmaceutical Products")
Effects Of X-Ray Inspection On Pharmaceutical ProductsSome manufacturers still have reservations about adopting X-ray inspection as a safe method of product inspection. Explore the potential effects of X-ray inspection on pharmaceutical products and more.
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![GettyImages-983797212-vial]( "Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing")
Correlating Laser-Based Headspace Analysis To Helium Leak Rate TestingLaser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.
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![GettyImages-1124712795-OSD-tablet-pill-capsule-oral-solid-dose]( "USP <922> Water Activity Testing For Oral Solid Dose Pharmaceuticals")
USP <922> Water Activity Testing For Oral Solid Dose PharmaceuticalsGain insight into the technical and regulatory justification for adding water activity measurements into pharmaceutical stability protocols.
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How To Select The Ideal Leak Testing Method For Your Application6/15/2022
Here, we present the pros and cons of electronic leak testing methods and their suitability for different leak detection applications as well as professional advice on selection criteria.
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CCIT Comparative Study Between Dye Ingress And Deterministic Methods1/13/2023
Explore the results of a unique comparative study of CCIT, and find a suitable deterministic test method to replace the blue dye test that follows the latest guidelines.
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AMI 1000 – An Innovative CCIT Solution For The Pharmaceutical Industry5/4/2022
This innovative CCIT solution based on Optical Emission Spectroscopy (O.E.S.) is an deterministic test method according to USP 1207 that can be used for in-process control during production or for laboratory purposes.
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Container Closure Integrity Of Product Requiring Deep Cold Storage8/26/2022
Gain insight into the risk to container closure integrity (CCI) during deep cold storage and identify appropriate analytical tools, to generate robust data to characterize and mitigate the risk to CCI.
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Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems6/7/2022
Learn how USP 1207, the reference standard for container closure integrity testing (CCIT), applies to the CCIT inspection method of intravenous (IV) bags.
PHARMACEUTICAL INSPECTION SOLUTIONS
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![SpeedAir 3050]( "Enhance Product Safety With A Non-Destructive Leak Testing System")
Versatile CCIT1 for a wide range of applications
The SpeedAir 3050 is your all-in-one solution for nonporous pharmaceutical applications. Whether your products are flexible or rigid, liquid or solid, the SpeedAir 3050 can swiftly and accurately test them all. With testing times as short as 30-45 seconds, it delivers results you can rely on, ensuring the integrity of your pharmaceutical containers.
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![Cap-fill level inspection]( "Cap & Fill Level Vision Inspection Systems")
A missing or cocked cap on a product package can result in unnecessary product waste and costly rework, which leads to lost profits. Our systems can quickly identify products with missing or improperly-applied caps, removing them from the production line and alerting operators to the issue.
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![Pfeiffer]( "Container Closure Integrity Systems For Pharmaceutical Drug Packaging")
While in the early development stage of packaging, the supplier is obliged to ensure that the packaging is by design capable of ensuring sterility. Therefore, the packaging must to be tested for defects in the range of 0.2 µm, respectively 6 * 10-6 mbar*l/s („maximum allowable leak level“; MALL). Based on a study from Kirsh, this is the defect size where the microbial ingress failure rate is 0 %. Integrity tests are mainly performed in the range of 2 to 20 µm defect size. The main reason for this is the feasibility of the available methods to detect smaller defects in a reasonable test time. When dealing with 100 % inspection of the production line that operates at speeds for 120 to 600 parts per minute, the allowed defect size is sometimes even increased to a significantly higher level. To compensate on the risk-based approach, additional off-line sample testing is performed to a tighter specification in the range of 1 to 10 µm. This also applies to stability testing which is performed in laboratory tests. Here again the sensitivity is more important than the test time.
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![A&V GS]( "Pharmaceutical Vision Inspection System For Syringes: A&V GS")
The A&V GS automatic inspection machines are designed for particles and cosmetic inspection of pre-filled syringes. The versatility of these machines allows to inspect water-like and viscous products.
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![lonza]( "Container Closure Integrity Testing")
Lonza’s Drug Product Services delivers a holistic approach to DP development that prevents problems early and produces a product that is fit for purpose.
