Skip to main content
© BREVETTI CEA S.P.A | c.f. e p.i. IT/01852870243 | Via del Commercio, 28 - 36050 | Sovizzo (VI) Italy

Container Closure Integrity & Media Fill

Brevetti CEA cutting-edge technologies for leak detection and media fill testing are specifically designed to support our valued customers in achieving compliance with the latest regulatory standards, including the new EU GMP Annex 1.

CCI

Advanced Automatic Leak Detection Solutions
for Compliant Container Closure Integrity (CCI) Testing

The revised EU GMP Annex 1, which focuses on sterile medicinal products, introduces stringent guidelines to ensure the maintenance of CCI throughout the product lifecycle. The updated Annex 1 places significant emphasis on CCI testing methodologies, recognizing the critical role of preserving container closure integrity in safeguarding product quality and patient safety.
Brevetti CEA's commitment to excellence has driven to the development of innovative and state-of-the-art automatic leak detection solutions that meet and exceed the evolving requirements outlined in the new EU GMP Annex 1.

Key Features and Benefits of Brevetti CEA Automatic Leak Detection Solutions:

Non-Destructive Testing:

Brevetti CEA advanced system employs non-destructive testing methods, minimizing product waste and reducing costs associated with traditional leak testing methods, such as vacuum decay.

High Precision:

Brevetti CEA solutions boast exceptional precision, ensuring that even the most minute breaches in container closure integrity are identified and addressed.

Real-Time Monitoring:

Brevetti CEA automated systems provide real-time monitoring, enabling continuous inspection and rapid detection of any potential leaks.

Compliance Assurance:

Brevetti CEA system is fully compliant with the latest regulatory standards, including the updated EU GMP Annex 1, ensuring that your facility meets the stringent requirements for container closure integrity testing.

Brevetti CEA offers integrated and stand-alone leak testing solutions for liquid and freeze-dried pharmaceutical products based on different non-invasive, non-destructive testing methods.
Experience the future of container closure integrity testing with Brevetti CEA.

High Voltage Leak Detection
in Liquid (HV)

Pinhole, cracks and pierced needle shield inspection can be detected by the well-known and widely proven HV principle based on the measurement of electrical conductivity of sealed containers using a high voltage electric field. LD module is the synthesis of more than thirty years of Brevetti CEA expertise in the inspection and leak detection world. Available as stand-alone machine, it can also be used in combination with our inspection machines, becoming the most compact and performing "Inspection Lines" for liquid filled ampoules, vials, syringes and cartridges available on the market.

Head Space Gas Analyzer in Freeze-dried (HGA)

Based on TDLAS spectroscopic technology, the laser is modulated in frequency to assure a more accurate, stable and reliable measurement. Light absorption is proportional to oxygen concentration in the optical path. The system can discern oxygen-free (good) containers from the ones contaminated by oxygen due to leakage or process fault.
The installation of HGA leak detection unit into an automatic inspection machine integrates the classic detection capabilities of visual inspection and it represents the state-of-the-art in terms of leak detection in products filled under low oxygen concentration or modified atmospheres (nitrogen).

MEDIA FILL

The media fill procedure is a vital quality assurance and validation test conducted in sterile manufacturing environments, particularly in the production of injectable drugs. It is a simulation of the actual drug manufacturing process and is designed to ensure that aseptic processing is conducted without microbial contamination.

Validation:

It validates that the aseptic manufacturing process is capable of consistently producing sterile drug products. Any deviations or contamination during media fill testing prompt corrective actions to improve manufacturing procedures.

Training and Personnel Competency:

It helps evaluate the proficiency of personnel involved in aseptic processing. If issues arise during media fill, it may indicate the need for additional training or improved aseptic techniques.

Regulatory Compliance:

Regulatory authorities require pharmaceutical manufacturers to conduct media fill tests to demonstrate compliance with Good Manufacturing Practices (GMP) and ensure product safety.

Risk Mitigation:

By identifying and rectifying issues through media fill testing, manufacturers reduce the risk of producing contaminated drugs that could harm patients.

The procedure includes the following steps:

1. Preparation

A sterile microbiological growth medium, often a nutrient-rich broth or agar, is used to replace the actual drug product.

2. Simulation

The manufacturing process is simulated, typically involving the same equipment, personnel, and procedures used for actual drug production.

3. Incubation

The containers filled with growth medium are incubated under conditions that promote microbial growth.

4. Inspection

The containers are thoroughly inspected for any signs of microbial growth. Any contaminated units are meticulously analyzed to identify the source of contamination and rectify procedural issues.

Can automatic inspection support the Media Fill Process?

Yes! Several inspection units typically installed in Brevetti CEA inspection machines can play a pivotal role in supporting the media fill process.

Turbidity Detection:

This inspection unit has been specifically designed to monitor the product turbidity, a common indicator of bacterial presence, in media fill. It excels in detecting microorganisms like Staphylococcus aureus and Stenotrophomonas maltophilia, which can cause turbidity in the growth medium. By precisely identifying turbidity, this inspection camera aids in the early recognition of potential bacterial contamination.

Agglomerates Inspection:

Brevetti CEA developed an algorithm to detect the presence of bacteria that may generate agglomerates without causing turbidity (i.e. the bacterium Aspergillus brasiliensis).

HGA (Head Space Gas Analyzer):

This unit identifies bacteria that consume oxygen, leading to a reduction in oxygen levels within the container. When combined with the insights from the turbidity and agglomerates inspections, the HGA camera reinforces the analysis, especially with some specific bacteria, such as Pseudomonas aeruginosa.
In a remarkably efficient time frame, spanning from 18 to 36 hours, this comprehensive trio of inspection systems diligently monitors the growth of tested bacteria. The data obtained through this integrated approach empowers precise and timely detection of potential contamination.
Elevate your media fill procedure, contact our experts today to know more!