Sterile Product Storage & Transportation Mistakes To Avoid For Start-ups
Appropriate storage conditions (e.g., drug storage and drug transportation conditions) are critical to maintaining sterile product safety, stability, and efficacy. Many common startup mistakes can be avoided through pre-planning the storage and transportation conditions of finished sterile products such as cosmetics, medical devices, vaccines, biologics, biotechnological products, radiopharmaceuticals, and combination products. Indeed, one of the most common startup mistakes for medical devices is not accounting for medical device storage temperature requirements. For many companies, manufacturing activities occur overseas. Overseas manufacturing makes storage and transportation over the product’s lifetime particularly important, as finished products may be driven or flown for several hours before reaching their final destination. Out of all of the environmental controls affecting product quality and stability, the temperature is one of the most important (if not the most important) parameters to control. Even brief exposure to temperatures outside labeled storage conditions can impact product safety, quality, and efficacy. Thus, it is essential to assess medical device/drug storage or medical device/drug transportation risks and have strategies to mitigate them to maintain sterile product functionality. Product and process knowledge are needed to make a risk-mitigation strategy that avoids storage and transportation mistakes, while maintaining appropriate storage conditions.
Examples of sterile product knowledge are:
- Intended use
- Storage conditions (including drug storage conditions and medical device storage temperatures)
- Potential hazards to the environment and personnel (e.g., cytotoxic drug products or radiopharmaceuticals)
- Inherent vulnerability (e.g., attractiveness for cargo theft)
Examples of sterile process knowledge are:
- Knowledge of supply chain partners
- Modes of transportation (air, sea, rail, road, etc.)
- Transportation routes (timing of routes for drug transportation etc.)
- National and international regulations and documentation
Risk mitigation strategies fall within four categories:
- Documentation
- Training
- Resources
- Qualification & Validation
Process mapping and flow charts are useful to support risk identification (what could go wrong) and mitigation (risk reduction or elimination). Documentation risk mitigation often involves setting up instructions for operation, whereas training risk mitigation ensures employee competence with assigned tasks. Resource mitigation strategies cover physical resources, human resources, and infrastructure, whereas qualification and validation mitigation ensure that resources and processes are reliable, reproducible, and robust. Generally, any successful risk identification and mitigation systems should allow companies to plan, implement, measure, and improve their processes according to current regulations and known risks. Some of the top risks for sterile product storage and transportation (including drug storage, drug transportation, and how to overcome risks) are listed below.
The top sterile product storage and transportation mistakes to avoid are:
#1: Human error due to incorrect product selection, excessive duties, lack of training or competence
Human error can result in mishandling along the supply chain, affecting product quality, product integrity, appropriate product selection for shipment, and patient safety. Quality, integrity, and safety issues can be avoided with adequate training of employees in standard operating procedures (SOPs), assigning an appropriate number of individuals to a task, and assigning personnel to tasks that they are qualified to complete. Product selection issues can be mitigated with automated checking systems or secondary-person validations.
#2: Buy from or sell to unlicensed trading partners
Buying from or selling to unlicensed trading partners can have embarrassing legal ramifications and affect patient safety. This is especially true when it comes to drug transport and drug storage. Checking for supplier qualification, customer qualification, and the currency of licensure will mitigate most issues. Also, ensure quality agreements between the supplier and trading partners are accurate and require appropriate licensure assessments.
#3: Shipping or receiving adulterated, falsified, or recalled product
Falsified or recalled products put patients at risk for illness and injury. Mitigation strategies include product quality control testing, packaging identification fingerprints, recall SOPs, appropriate communication with regulatory authorities and trading partners regarding recalls, and ongoing performance qualifications for manufacturers.
#4: Receipt of a product that was not ordered
Receiving a product that wasn’t ordered often occurs from mismatched paperwork linked to customer order. In extreme cases, an illegitimate or counterfeit product may have been introduced into the supply chain. Mitigation includes establishing standard operating procedures that cover order and supply chain transactions. Use automation where possible to avoid mixups due to human error.
#5: Mixing products with a different status (e.g., rejected, recalled, or returned)
Mixing new, rejected, recalled, or returned products can jeopardize patient safety. Mitigation strategies for this hazard include implementing robust product segregation (preferably by physical location), shifting the warehouse layout to logical product flow, and creating holding areas to avoid mixups.
#6: Shipping and receiving delays due to inclement weather, natural disasters, and traffic disruption
Unexpected weather, traffic, and natural disasters can cause products to experience temperature fluctuations outside of their specification and arrival delays. Both of these situations could affect patient safety. Mitigation strategies include rescheduling deliveries to avoid weather, choosing packaging materials that will ensure ideal temperatures will be held in inclement conditions, off-loading packages to a temperature-controlled facility or vehicle during weather-related events, and monitoring protocols to ensure product integrity. Ensuring that medical device storage temperature requirements and drug storage temperature requirements are met for the entire journey is a must. All worst-case weather and traffic situations should be taken into account, especially for items that require strict climate controls.
#7: Improper entries into a materials management system (e.g., wrong batch number, wrong expiration date, wrong status, or wrong amount
Improper entries can be human error or inaccurate product labeling (e.g., shipping product that should have been quarantined but was marked approved). Strategies to avoid improper entries into management systems include SOP adherence and the use of validation software/automation.
#8: Product stored in the wrong physical location
Products stored in the wrong location may be inappropriately shipped to customers or experience temperatures outside their designated storage conditions (e.g., exceed medical device storage temperature requirements). Further, legal sanctions are an issue for any controlled substance outside of designated areas. Strategies to prevent incorrect product storage include implementing automated checking systems and using SOPs for product stocking, temperature, and license categories.
#9: Storage environmental conditions are not met
Product quality, integrity, and safety are questionable if products are accidentally heated or cooled to temperatures outside of their stability range. Questionable products cannot be sold and result in financial losses and problems with patient product availability. Issues with product loss due to storage conditions can be prevented by utilizing warehouse, packaging, and transportation temperature mapping, implementing product storage identification, using homogenous airflow within storage areas, regular monitoring and calibration of alarms (for temperature, humidity, etc.), and adherence to SOPs. Drug transportation temperature mapping is particularly important for climate-sensitive therapies so that appropriate storage conditions are met.
#10: Storage or temperature system failure due to extreme conditions
Risk #10 is very similar to #9. However, mitigation of system failures due to a loss of electrical power, temperature control failure, air circulation systems, or an unusual weather event are handled with backup monitoring devices and backup power systems for storage and transport. These backup systems function independently of on-grid systems and ensure appropriate storage conditions are met.
Summary
Overall, appropriate storage conditions and transportation conditions are critical to maintaining sterile product safety, stability, and efficacy. Finished sterile products include cosmetics, medical devices, vaccines, biologics, biotechnological products, radiopharmaceuticals, and combination products. For many start-ups saving money, manufacturing activities occur overseas. This makes storage and transportation over the product’s lifetime particularly important, as finished products may be driven or flown for multiple hours before reaching their final destination. The top risks for start-ups to overcome during product storage and transport are: 1) Human error, 2) Buying from or selling to unlicensed trading partners, 3) Shipping recalled product 4) Receipt of product that was not ordered, 5) Mixing products with different status 6) Shipping and receiving delays due to inclement weather and traffic, 7) Improper entries into management systems, 8) Product stored in the wrong physical location, 9) Storage environmental conditions are not met 10) Storage or temperature system failure due to extreme conditions. All in all, ensure you choose a contract manufacturing organization that can support your sterile product needs.
MycoScience is a contract manufacturing organization specializing in sterile syringe and vial filling. MycoScience also offers Preservative Efficacy Testing, Sterilization Validations, Bioburden Testing, Cleaning Validations, Microbial Aerosol Challenge Testing, Accelerated Aging, Microbiology Testing, Cytotoxicity Testing, Bacterial Endotoxin Testing, EO Residual Testing, Package Integrity Testing & Environmental Monitoring services medical devices and allied industries. MycoScience is an ISO 13485 certified facility.
References
United States Pharmacopeial Convention. <1079> Risks And Mitigation Strategies For The Storage And Transportation Of Finished Drug Products. Rockville, MD, USA. 2021. (USPC <1079>).
Michael J. Akers. Sterile Drug Products Formulation, Packaging, Manufacture, and Quality. Drugs and the Pharmaceutical Sciences. Informa Healthcare. 2010.
