The Importance of Quality Management in
Biohazard Transport Packaging
Quality Control (QC) and Quality Assurance (QA) are two aspects of quality management that ensure thorough and reliable high-quality manufacturing of a product. They require the implementation of stringent procedures, regulations, audits and inspections to be done properly and they are necessary for customer safety and confidence, a crucial aspect for any biohazard transport packaging.
At shuttlepac we take this very seriously because we know how important it is when purchasing from a manufacturer that you can 100% trust every single product. Our Biohazard Transport pouches are manufactured under Good Manufacturing Practise (GMP) and shuttlepac is accredited to ISO 9001 2015, and that is only the start of our Quality Management System (QMS).
The government guidelines (https://www.gov.uk/government/publications/packaging-and-transport-requirements-for-patient-samples-un3373/packaging-and-transport-requirements-for-patient-samples-un3373) for Biological Substances, Category B are a series of regulations that are required of packaging for the transport of biohazardous materials. These guidelines have come further into the public eye proceeding the global pandemic, due to such high volumes of potentially biohazardous patient samples being transported between patients and testing labs all across the world. These regulations are in place to protect the patients and our keyworkers that are handling the post and processing the samples in the laboratory.
This is the bare minimum of what is required, but shuttlepac have gone above and beyond those minimum levels of safety to ensure maximum protection to all parties that will handle the package, you can read more about this in our last blog post here in case you missed it.
GMP
Good Manufacturing Practise, is a series of rules and best practises that are designed to control the quality of consumable goods before they are sold. This helps to protect manufacturers improve and maintain their quality, as well as protecting consumers from faulty goods. The guidelines cover many aspects of quality, across many industries.
In the packaging industry, specifically for healthcare it covers issues such as contamination, correct labelling, flush edges and in our case: UN3373 compliance.
Why is it important?
As well as this, it helps to protect the manufacturers staff and equipment as it will also cover things such as training, procedures, and equipment testing. There are known to be the “5 Ps” of GMP (Figure 1) which cover all aspects of this.
Error in manufacturing cannot always be caught, especially when production is large scale. The implementation of these guidelines which are common across all manufacturers in an industry, ensures that every single batch of a product is of the same high quality and provides the same level of safety as whichever unit was checked.
It protects consumers, purchasers, and distributers from purchasing something that doesn’t live up to expectations or could be potentially dangerous. This reliability and trust in a brand, is also important to maintain that customer base over time.
GMP also saves manufacturers money by allowing them to catch errors early and prevent them going to market which prevents any kind of costly bills or recalls and subsequently reputational damage. The average annual cost of maintaining GMP is estimated to be around £33,000 for a small business of less than 20 employees, but the cost of recalling a product can be into the billions [1]. One example is the recall of Rofecoxib (Vioxx), an arthritis medication made by Merck due to its increased risk of heart attacks: this cost the company $4.85 billion (£3.49 b) [2].
How do shuttlepac manage quality?
Here at shuttlepac we have 6 purpose-built machines that manufacture the ShuttlePouch™. All machinery, staff and procedures adhere to GMP, ensuring reliability on flawless quality. We have produced over 16 million units and have not received a single complaint. 100% happy customers!
Contact us today to find out more about how we can solve your biohazard transport packaging needs.