Demonstration of fitness for purpose in supply is a vital element in new product and pack development, and for the pharmaceutical and medical device sectors this is a mandatory/regulatory requirement (for FDA, MHRA and EMEA approval and compliance with ISO 11607, ASTM D4169).
We understand the importance of getting your product to its end-user in a fit-for-purpose condition. Smithers has unrivalled facilities capable of simulating the range of events occurring from point of manufacture to point of sale and use.
No matter how simple or complex your supply chain, transit or packaging scenario - we can design a testing and evaluation program to meet your needs.
Our transit and package testing services help clients:
- Achieve regulatory compliance
- Validate packaging performance
- Reduce damage
- Reduce packaging costs
- Reduce lead time to launch
- Assess durability of tamper-evident features
- Assess abrasion resistance of packaging and labels
Our laboratory facilities can simulate and assess:
- Vibration in truck, plane, van, car or train
- Shocks, drops and impacts typical of palletised and indivudal packages in distribution
- Thermal and climatic hazards (elevated temperature, elevated humidity, frozen and chilled chain distribution and climatic cycling - cabinets and walk-in pallet scale chambers available).
- Low pressure performance (associated with high altitude transport by air and road)
- Compression assessment (recreating warehouse and vehicle stacking)
- Load stability in vehicle and during handling
- Shock and fragility performance
- In-use / patient handling
- The effects of aging
We also provide post transit integrity assessments
, to ensure the integrity of packaging / product is not compromised as a result of distribution and aging.
Quality and Accreditation
Our laboratories are ISTA certified and ISO 17025 accredited for a range of specific tests related to medical packaging. Many of the team members in both the US and UK are ISTA certified members and are globally recognized for their knowledge and expertise.