The revised Annex 1 guideline, released in August 2022, includes specific requirements related to container closure integrity. Clause 8.24 states:
“Containers sealed under vacuum should be tested for maintenance of vacuum after an appropriate pre-determined period prior to certification/release and during shelf life.”
While testing for presence of headspace oxygen is more commonly known and understood by industry, the requirement for testing total pressure/presence of vacuum in the headspace of containers sealed under vacuum is relatively less known and less understood.
The Annex 1 further states in clause 8.25:
“The container closure integrity validation should take into consideration any transportation or shipping requirements that may negatively impact the integrity of the container (e.g. by decompression or extreme temperatures).”
This clause (8.25) adds a further dimension to the Clause 8.24 since it can be interpreted to link the storage and transportation conditions to the integrity of the container and thus the shelf life of the product.
While the implications of Clause 8.25 is debatable on the conditions to be simulated while testing, what is not debatable is that presence/maintenance of vacuum in the headspace is to be tested.
Let’s understand how this can be done.
Understanding Wilco’s Laser based Technology for Testing Headspace Conditions
Wilco uses the non-destructive Tunable Diode Laser Absorption Spectroscopy (TDLAS) to test for different gases.
Gases have specific absorption lines at different wavelengths:
- Oxygen can be detected at a wavelength of 760 nm and is used to read concentration of oxygen as low as 0.03% in the headspace.
- Moisture can be detected at a wavelength of 1400 nm and is used to read total pressure/maintenance of vacuum in the headspace.
- Carbon Dioxide can be detected at 2000 nm and is used to read concentration of CO2 in the headspace which can be indicative of microbial activity.
Wilco’s 4th generation Laser Heads are adapted to various testing platforms which can offer manual statistical testing as well as 100% testing at high speeds of upto 600 cpm.
Here’s a quick look at the multiple platforms that are on offer:
Table Top Statistical Testing-Single Laser Platform
The NEO HSX ONE is a non-destructive headspace analyser which can be fitted with either Oxygen Laser Heads or H2O Laser Heads.
It has a special adjustable handling ability which can test different container formats without the need for specific change parts.
For example it can test vials from 2ml to 100ml using a common change part.
Inserts are available using which smaller diameter containers like ampoules and PFS can be tested in the same change part.
It has a unique feature which enables testing of liquid filled containers with a high fill volume where availability of adequate headspace is a challenge.
The updated “MAVIS” intuitive software offers full 21CFR11 compliance.
By combining precision, flexibility and efficiency, it serves as a robust solution for headspace analysis challenges.
Table Top Statistical Testing-Dual Laser Platform
The NEO HSX DUO is a non-destructive headspace analyser which can be fitted with both, an Oxygen Laser Head and a H2O Laser Head.
It offers all the features, efficiency and flexibility as the NEO HSX ONE -Single Laser platform BUT with the added advantage of having the ability to read Headspace Oxygen as well as Total Pressure/Vacuum in the headspace.
This enables substantial savings in investment due to using a common platform while offering dual purpose testing which can aid Annex 1 compliance.
Inline 100% Small Batch Testing-Single or Dual Laser Platform
The Spectra HSX 100 is a compact inline testing platform which can be fitted with ONE or TWO different Laser Heads to offer flexibility in testing Headspace Oxygen or Headspace Moisture/Pressure/Vacuum.
It offers speeds upto 100cpm for 2ml vials and upto 40cpm for 100ml vials.
Inline 100% Large Batch High Speed Testing Laser Platform
The Spectra HSX 300 and HSX 500 series is a high speed inline testing platform which can be fitted with one or more Laser Heads to offer high speeds of upto 300 to 600 cpm in testing Headspace Oxygen or Headspace Moisture/Pressure/Vacuum.
Inline 100% Multi Inspection Platform
The VARIO MTX series is a customised modular inline testing platform which can be fitted with a combination of different inspection technologies like Headspace Analysis, CCIT, NIR Spectroscopy for residual moisture in Lyo cakes and Camera Based Inspection of Cosmetic defects.
Summing Up
Wilco AG based in Switzerland offers multiple technologies for Head Space Analysis and CCIT for sterile containers.
More details can be found at www.groverholdings.com and www.wilco.com or you can get in touch with us at [email protected] or call on +91 98211 11623.