Leak & Flow Testing Equipment

  1. Container Closure Integrity Testing (CCIT) For Pharmaceutical Syringes 8/9/2024

    Container closure integrity (CCI) testing for pharmaceutical syringes is essential to confirm that syringes maintain their sterility and ensure the safety and effectiveness of their contents. Accurate CCI testing prevents contamination and guarantees that the injectable product remains free from leaks or defects in the seal.

  2. Container Closure Integrity Testing (CCIT) For Pharmaceutical Vials 8/9/2024

    Container closure integrity testing (CCIT) is crucial in the pharmaceutical industry to ensure that vials maintain their sterility and product quality throughout their shelf life. These systems are designed to detect any leaks or defects in the vial's seal that could compromise the product.

  3. Enhance Product Safety With A Non-Destructive Leak Testing System 10/29/2023

    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.

  4. Pharmaceutical Leak Testing Services 4/17/2023

    Pharmaceutical leak testing is a crucial process for ensuring the safety and sterility of medical and drug packaging, particularly in applications such as CCIT Test Method Validations, pilot production runs, and small-scale production runs. While pharmaceutical manufacturers may not have the resources to invest in leak testing equipment or trained personnel, inadequate testing can have serious consequences. In this article, we will discuss the leak testing services offered by Pfeiffer Vacuum and how they can help manufacturers meet regulatory requirements and ensure the safety of their products.

  5. Pharmaceutical Mass Extraction Vacuum Leak Testing Equipment For Vials And IV Bags 8/3/2021

    Our USP <1207> and ASTM (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV bags, pouches, or glass vials. Larger defect and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as well as automated 100 % testing (also in inline machines).

  6. Optical Emission Spectroscopy Equipment For CCIT 8/3/2021

    Our patented O.E.S. (Optical Emission Spectroscopy) method does not require any specific tracer gas. Instead, the gas mixture present in the container headspace of the primary packaging is used to perform high sensitivity tests with high throughput. A multi-gas sensor is used to independently track the different gases (i.e. argon, nitrogen, CO2, humidity,…) escaping from a leaky container exposed to vacuum. Our method is non-destructive, deterministic, easy to use and to set up, faster and has higher sensitivity than other conventional methods. O.E.S. is able to detect down to 0.2µm defect size on glass containers which corresponds to the sterility barrier defined as the MALL (Maximum Allowable Leak Limit) in the USP<1207> guidelines.

  7. Container Closure Integrity Systems For Pharmaceutical Drug Packaging 8/3/2021

    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.

  8. Pharmaceutical Container Closure Integrity System – Sterility Property Physical Testing 9/23/2019

    There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier. Whether you are testing sterile barrier, a moisture barrier or general protection packaging we can offer nondestructive container closure integrity test equipment.

  9. CCIT For Moisture Ingress & General Protection 9/23/2019

    There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier. Whether you are testing sterile barrier, a moisture barrier or general protection packaging we can offer nondestructive container closure integrity test equipment.

  10. Medical Device Packaging Seal Integrity Testing Equipment 9/23/2019

    Pfeiffer Vacuum applications are Ideal for medical device and medical package leak testing. Unlike pressure decay, we offer a faster, more accurate test as well as direct measurement capabilities that are not volume sensitive.