Company insight
Ensuring the integrity of pharmaceutical packaging
Products used by the medical and pharmaceutical industry need to comply with the highest quality and documentation standards in order to protect human lives. Pfeiffer Vacuum’s solutions are used for the sterilisation of medical devices, the production and preservation of drugs, and highly sophisticated technologies like particle therapy for cancer treatment. Pfeiffer Vacuum offers a complete range of products to support those applications and constantly strives for innovation to further improve the safety and quality of pharmaceutical products.
egardless of whether the packaging is glass bottles, ampoules, blisters or even IV bags, a tight and reliable seal is essential when it comes to primary packaging for medical products. There are various reasons for this. With many medicines, the penetration of moisture or oxygen must be prevented in order to ensure their efficacy over the entire shelf life. And in the case of sterile parenteral products, biological contamination poses a serious risk of infection for the patient.
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Clear rules for leak testing (CCIT) This is why there are clear rules on testing the leak tightness and integrity of pharmaceutical container closures – container closure integrity testing (CCIT). Even in the early development phase of a packaging, the supplier is obliged to make sure that the packaging is designed to ensure sterility.
The packaging must therefore be tested for defects <0.2μm or 6 · 10-6
mbar · l/s –
this is the maximum allowable leak level (MALL). This makes sense, because studies have shown that even a 2μm leak
carries a risk of almost 70% for the contamination of a medicine.
Helpful: the USP 1207 guideline These regulations do not describe in detail how CCI testing should be carried out. Therefore, in 2016, the US authority Pharmacopeia presented USP 1207 for the first time, a guideline that focuses on the packaging of sterile and critical pharmaceutical products such as vials, ampoules and syringes. The guideline is divided into three chapters: ■
1207.1: Package integrity and test method selection ■
1207.2: Package integrity leak test technologies ■
1207.3: Package seal quality testing methods.
The Pharmacopeia guideline provides a good overview of suitable methods for integrity testing of pharmaceutical packaging. However, it does not claim to describe all methods. And since standards and guidelines generally refrain from specifying certain technologies, it does
not give recommendations on which test method to select for individual applications.
No statement about the method to be chosen Without in-depth knowledge of the methods, however, the user can hardly be expected to make a purposeful decision. For example, with the blue dye test, which is quite useful in some applications, the probability of detecting a leak of 10µm is only 70%. Leaks below 5μm can scarcely be detected. The method is therefore unsuitable for CCI tests. The same applies to optical measuring methods that work according to the principle of deflection. Here, too, the detection limit is about 5μm.
Test methods: The user has the choice
There is no single solution that fits all the challenges associated with a particular product or project. So, the user has to choose which methods come into question and which criteria to apply when making a decision. According to Pfeiffer Vacuum, there are several suitable methods: helium mass spectrometry, mass extraction and optical emission spectroscopy.
Help is on hand
There are several proven and purposeful methods available. Pfeiffer Vacuum supports the user during the entire CCIT process, definition and integration process and GMP procedure (IQ/OQ), including the required documentation. In its pharmaceutical laboratories, Pfeiffer Vacuum also conducts extensive feasibility studies and acquires in-depth process knowledge for the user. ●
Left to right: the ME2 mass extraction leak tester, AMI 1000 optical emission spectroscopy leak detector and ASM 2000 helium mass spectrometry leak detector.
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
www.pfeiffer-vacuum.com 45
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