Pharmaceutical components need to be free from contaminants and pathogens. After all, the industry’s focus is to provide relief to patients—not to cause further issues.
Pre-sterile components help maintain contamination-free drug manufacturing and delivery better than the conventional in-house sterilization method. You don’t have to hire extra operators and purchase the necessary sterilization equipment. Storage and maintenance expenses also go down.
Furthermore, you can focus on making better drugs and leave the process to an expert. Thus, these solutions immensely boost a pharmaceutical company’s efficiency and cost-saving efforts.
Pre-sterile components also contribute to sustainable manufacturing practices in today’s environmentally-conscious world. Energy-consuming in-house sterilization processes such as cooling, heating, and transportation plummet significantly.
Let’s dive deeper to understand the meaning of pre-sterilized components, examples of ready-to-use packaging solutions, and how your company can reap these benefits.
What are Pre-sterilized Components?
Pre-sterilized components are primary, ready-to-use (RTU) drug packaging solutions that are already sterilized before being delivered to you. These solutions have gained popularity recently due to their immense value in streamlining final drug production steps.
Manufacturers of these RTU solutions use steam autoclaves, dry heat, gamma rays, and other sterilization methods. They then pack and transport the solutions to pharmaceutical companies carefully.
Some of these packaging components include:
- Stoppers: Close vials and syringes
- Vials: Store drugs in liquid form
- Seals: Seal syringes and vials
- Cartridges: Store medications in pre-filled syringes and pens
- Surgical instruments: Instruments surgeons use in surgical procedures. They include scalpels, scissors, and forceps.
The skyrocketing use of these products is due to the significantly reduced costs, minimized contamination risks, and boosts in efficiency.”
Pre-sterilized Components and Efficiency
More pharmaceutical firms are turning to pre-sterilized ready-to-use (RTU) components because they inject efficiency into manufacturing. This advantage was particularly crucial during the pandemic-induced surge in demand for drugs. And now that companies have realized the benefit, there’s no looking back.
In-house traditional sterilization of packaging components usually uses vast chunks of time. You need specialized sterilization and validation procedures to ensure no pathogen gets to the patient.
The traditional procedure also requires you to train operators and maintain the equipment. These are other time-consuming tasks that usually cripple operations.
That’s where pre-sterilized components come in to eliminate extra steps in your manufacturing process.
The hefty in-house sterilization equipment demands a lot of space. On the other hand, you can order pre-sterilized RTU components only when you anticipate their need. That way, you slash the cumulative space and time needed to sterilize, validate, store, and retrieve them.
Furthermore, the traditional procedure demands careful monitoring of parameters such as exposure time, temperature, and pressure. Any minor variation from acceptable standards means you must repeat the process to avoid compromising drug safety.
Pre-sterilized components eliminate these errors, variabilities, and complexities of in-house sterilization. The solutions will come with a quality certificate indicating that they were manufactured using a validated process and any testing results, such as sterility, endotoxin, and particulate.
Lastly, unexpected supply chain interruption on top of in-house inefficiencies can easily cripple a company. Therefore, embracing pre-sterilized components is a crucial solution to such modern challenges.
Pre-sterilized Components and Cost Savings
Drug fill is a capital-intensive undertaking requiring heavy infrastructure and expertise investment. For example, an electron accelerator for electron beam sterilization can cost at least $ 1 million. And the entire e-beam establishment project can cost you a minimum of $2 million.
Additionally, today’s drugs are getting more complex and costlier—for example, the production of small-batched gene therapies and monoclonal antibodies. So drug producers are always hunting for leaner and more cost-effective packaging solutions to meet this demand.
Pre-sterilized RTU packaging comes to their rescue here too.
As mentioned, these components eliminate or reduce time-consuming and expensive in-house sterilization. Leave the job to specialized suppliers with the necessary expertise and equipment to ensure reliability and consistency. This trick saves you the cost of maintaining sterilization equipment, hiring, and training operators, and validating the process.
Additionally, the elimination of in-house sterilization translates to a reduction of costly errors, variability, and contamination. Pre-sterilized components boost product and process quality, reducing the need for rework, scrap, and product recalls. The result is faster production, lower labor costs, and higher throughput.
Pre-sterilized components also help reduce regulatory costs. As you know, the pharmaceutical industry is among the most regulated sectors. Any incidence of poor safety and quality can quickly attract the attention of regulators. The issue can escalate rapidly, costing you thousands of dollars in fines, legal fines, damaged brand reputation, and loss of customers. But leaving the sterilization task to experts helps reduce contamination.
Pharmaceutical companies can also leverage economies of scale by buying pre-sterilized packaging in bulk. The result is reduced costs per unit and overall production costs, boosting your bottom line.
Quality Control for Sterilized Components
It’s crucial to take relevant quality control measures to ensure the safety and efficacy of pre-sterilized components. This task must start before the packaging solutions come to your facility. You need to provide the vendor has these qualities:
1. Complies with set regulations
Strict FDA regulations like current good manufacturing practices (cGMP) govern pharmaceutical companies. Ensure your vendor adheres to them.
Which other companies does the supplier serve? Do they allow auditing? Dig deeper into their regulatory history to ensure they adhere to validated processes. Don’t proceed with any vendor that fails to show proof of compliance.
2. Has the relevant expertise
It’s common for suppliers to deal with various equipment and components spanning the vast field of medicine. But consider a supplier who supplies pre-sterile solutions in your specific niche.
A supplier worth their salt also handles these products carefully during the transit from their facility to yours. They should use suitable equipment when handling, transporting, and storing delicate components.
Avoid brokers who don’t understand the pre-sterile RTU packaging industry at all costs.
3. Reliable
Consistent quality is non-negotiable in the pharmaceutical industry. Your chosen vendor should deliver top-in-class products without delays.
Peruse their documents to ensure they have solid experience working with companies in your niche. Furthermore, they should have enough capacity to satisfy your unique demands.
4. Quality management system
Don’t rush to grab a supplier before ensuring they have robust QMSs to satisfy the strict quality standards. A reputable vendor has QC and QA processes and personnel specialized in pre-sterilized components.
Conduct an onsite visit to review their manufacturing procedures, QC, and equipment. How do they do their sterility tests? Do they pack the components in materials that maintain sterility throughout the trip to your facility?
How does the QC for pre-sterilized components differ from the traditional process?
Because pre-sterilized components come ready for use, they don’t have to go through the in-house QC process. Just ensure you’ve done your due diligence like a pro. Here are some of the traditional steps:
- Sterility test: Detects the presence or absence of pathogens in the packaging material.
- Equipment calibration: Comparison of equipment’s measurements with a standard of known accuracy.
- Validation of sterilization cycles: Confirming sterility tests using biological indicators.
- Documentation/Batch record release
- Environmental monitoring
- Routine maintenance and preventive maintenance
- Internal audits
- External quality assurance programs
Pre-sterilized Components and Sustainability
Apart from high costs and inefficiencies, environmental degradation is another issue that continues to haunt manufacturing companies. Companies worldwide strive to stay in the right books of environmentally-conscious consumers and governments. The use of pre-sterilized components is among their sustainable manufacturing practices.
In-house sterilization involves heating, cooling, and transportation. These processes demand a lot of energy and water, an issue that can skyrocket your costs. Pre-sterilized RTU components reduce this need since they come ready for use.
Replacing traditional procedures with RTU packaging also eliminates the generation of sterilization-related wastes. Such wastes are usually in the form of wastewater, disposable materials, and cleaning agents. Amounts of rejects due to contamination also goes down.
Furthermore, pre-sterilized packaging solutions aren’t as resource-intensive and time-consuming as in-house sterilization processes. That means companies that strive to adopt leaner manufacturing processes should consider them.
Conclusion
Pre-sterilized is among the time-saving innovations in the pharmaceutical industry. You can use them immediately after unpacking them, saving you the headache of sterilizing them in-house.
These solutions also save storage space. They don’t demand bulky supplies like autoclaves, allowing you to use your area more economically. Reliability is another advantage you get from pre-sterilized components. Reputable manufacturers adhere to strict FDA regulations to maintain the solution’s quality.
All these advantages lead to a significant benefit: Cutting costs—no more purchasing expensive sterilization equipment and hiring specialized personnel. You also minimize costly contamination errors.
But getting a reliable supplier of pre-sterilized components isn’t a walk in the park. That’s where Afton Scientific comes to your rescue.
For over two decades, we’ve supplied clients with reliable and high-quality RTU components in the US and worldwide. Since we are also a sterile injectable contract manufacturing organization (CMO), we are aware of the struggles that our customers experience. We use our own pre-sterilized, Ready-To-Fill vials and components during filling and can customize them to your filling needs.
Contact us today to reduce sterilization space, documentation, deviations, and costs.