Sealed means safe
The USA Code of Federal Regulations stipulates that pharmaceutical primary packaging must be sealed to ensure the integrity (quality) of the drug product as well as the safety of the consumer.
CFR 211.94 b: “Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.”
And CFR 211.132: “A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.”
Primary packaging is a vital element in the pharmaceutical manufacturing process and one that directly affects the drug being offered, its shelf-life and efficacy.
This raises the issue of testing; how can the manufacturer, dedicated to best quality, consumer safety and of course adhering to all the relevant guidelines and regulations, verify that 100% of packages coming off the production line are sealed to the standard that is needed for that particular product?
Sampling isn’t enough.
Sampling is the standard testing method today.
This method is limited in that it cannot detect discrete sealing discrepancies that can occur due to:
• defects in the raw material – bottle or liner
• problems in capping – false torque or crooked cap
• problems with the induction sealer – alignment, field fluctuations etc.
Sampling cannot provide reliable insight in to the quality or stability of the sealing process.
A high degree of process understanding enables line operators to not only detect problems but to prevent them from occurring in the first place. This and the understanding that quality cannot be tested into products but should be built-in by design are at the core of the FDA’s PAT Initiative.
Sampling as a testing method is not chosen for its efficacy. It is the standard method used today simply because no better method was available. Until now.
100%, in-line inspection
DIR leverages premium thermal imaging combined with sophisticated analysis algorithms to enable 100% in-line inspection. This highly sensitive, completely passive technology offers a quantum leap in quality assurance and process control - the transition from sampling to inspection of every single package.
DIR’s Induction Integrity Verification System (I2VS) inspects each package, through the closed cap, at the speed of the machine throughput. There is no interference or degradation of the product – nothing is projected at the package, the I2VS reads analyzes the inherent signature of the cap’s liner (which is amplified directly after induction).
In addition, the source of any faulty seals (i.e. damaged bottle, liner, etc., or an issue in the sealing process such as torqueing or capping), is indicated in real time, which provides a high degree of process understanding and enables operators to not only fix problems immediately, but prevent them from occurring in the first place.