ระบบตรวจสอบคุณภาพของ Prefilled Syringe แบบอัตโนมัติ (Automated Deterministic Inspection Technologies for Complete QC of Prefilled Syringes)
ระบบตรวจสอบคุณภาพของ Prefilled Syringe แบบอัตโนมัติ (Automated Deterministic Inspection Technologies for Complete QC of Prefilled Syringes)
ถ้าพูดถึงเทคโนโลยีระบบตรวจสอบเพื่อควบคุมคุณภาพความสมบูรณ์ของบรรจุภัณฑ์หลอดฉีดยา Deterministic Inspection Technologies for Complete QC of Prefilled Syringes และ Container Closure Integrity Testing (CCIT) ทุกวันนี้ บริษัทผู้ผลิตยาชั้นนำทั้งหลายต่างให้การยอมรับในเทคโนโลยี Vacuum Decay ในแง่ของความแม่นยำ ความน่าเชื่อถือ และความทนทาน การตรวจสอบเพื่อควบคุมคุณภาพความสมบูรณ์ของบรรจุภัณฑ์หลอดฉีดยา (Prefilled Syringes) และ Container Closure Integrity Testing (CCIT) กลายเป็นคำที่เราได้ยินกันบ่อยขึ้นในการทดสอบความสมบูรณ์ของบรรจุภัณฑ์หลอดฉีดยา (Prefilled Syringes)
ซึ่งจริงๆ แล้วมันก็คือ การพิสูจน์ว่าบรรจุภัณฑ์หลอดฉีดยา (Prefilled Syringes) นั้นๆ ยังมีความสามารถในการป้องกันสิ่งแปลกปลอมจากภายนอกได้ดีแค่ไหน ซึ่งในสถานที่ต่างๆ ก็จะมีออกซิเจนความชื้น แบคทีเรีย หรือการปนเปื้อนอื่นๆ ในอากาศแตกต่างกันไป เราอาจจะเคยได้ยินคำว่า Maximum Allowable Leakage Limit (MALL) ซึ่งถูกนำมากำหนดว่าบรรจุภัณฑ์หลอดฉีดยา (Prefilled Syringes) แต่ละแบบนั้น ควรมี CCIT แค่ไหน
ทั้งนี้ทั้งนั้นการทดสอบเพื่อการควบคุมคุณภาพที่สมบูรณ์ของหลอดฉีดยา Deterministic Inspection Technologies for Complete QC of Prefilled Syringes รวมทั้งบรรจุภัณฑ์ยาและเวชภัณฑ์ ที่ต้องการรักษาความสะอาด และการปราศจากเชื้อไว้ให้ได้ดีที่สุด ต่างก็หันมาใช้เทคโนโลยี Vacuum Decay โดยมีจุดเด่นเรื่องความเร็วในการทดสอบ การอ่านค่าที่แน่นอน และพิสูจน์การตรวจสอบได้กว่าระบบอื่นๆ และเป็นระบบที่เป็นมาตรฐานการทดสอบขึ้นทะเบียนใน ASTM methodologies, standard vacuum decay leak test method (F2338) ผ่านการรับรองโดย FDA ถูกบรรจุอยู่ใน ISO 11607 ซึ่งในการอ้างอิงในการทดสอบความสมบูรณ์ของบรรจุภัณฑ์หลอดฉีดยา (Prefilled Syringes) CCI (USP Chapter 1207) ซึ่งใช้เป็นมาตรฐานในบ้านเราเช่นกัน
Automated Deterministic Inspection Technologies for Complete QC of Prefilled Syringes
The pharmaceutical industry continues to lead industries in terms of quality requirements and the value of data. The shift to more automated processes is less about the cost of human capital, but more about the pursuit of quality. The European Medicines Agency (EMA) updated Annex 1, driving for 100% inspection on fused containers and appropriate quality test measures for applications based on level of risk. The United States Pharmacopeia (USP) revamped Chapter 1207 on container closure integrity (CCI) to be prescriptive of deterministic technologies and encourages a deeper understanding of a container’s CCI requirements. The FDA continues to drive a ‘quality culture’ agenda versus a ‘compliance culture’, and the FDA has been explicitly targeting data integrity as a campaign for assuring quality. Every regulatory and guidance body is driving towards more reliable and accurate test methods.
Automation and digital measurement systems have systematically become a greater part of pharmaceutical manufacturing. The ability to capture better quality data and provide a seamless data integrity solution is critical to these high-risk applications. Nowhere is this more evident than in the parenteral fill-finish environment. Considering the guidance documentation and vision of different regulatory bodies, focusing on CCI within the fill-finish arena becomes an incredibly effective space to develop a solution to assure CCI with the highest level of reliability in an automated fashion.
The future of pharmaceutical treatments lies in the advent of biologics. There is a significant amount of illnesses that are being treated with gene therapies, antibody drug conjugates and targeted therapies. Many of these treatments are small batch platforms with intermittent production. For most biologic operations with batches less than 10,000, 100% inspection of the batch without loss of sensitivity or assurance is a reality. Many parenteral operations are operating at line speed below 200 units per minute or filled by manual operators. For larger batches, statistically significant sampling can be effective. Regardless of the speed of the operation, applying robotic automated container closure integrity is a solution available today to support parenteral quality assurance.
Inspection Technologies Parenteral solutions continue to bring more complex delivery systems, and CCI testing is a final opportunity to address physical safety of the product in a manner that achieves all the objectives set by regulatory agencies. Either of PTI’s parenteral CCI solutions (HVLDmc or Vacuum Decay) can effectively be deployed for the wide range of parenteral package formats and application requirements in a robotic automated platform. Between the two technologies, 95% of parenteral applications can be tested for CCI down to critical to quality leak sizes.
HVLDmc and Vacuum Decay overlap in capabilities, but more importantly encompass the full parenteral market range. Both technologies are validated as non-destructive methods with leak detection sensitivity down to critical parenteral leak sizes. The technologies are specifically called out in USP’s Chapter 1207 and have been the subject of depth of scientific research supporting the effectiveness of the measurement solutions. A robust inspection solution to meet the needs of the biologics industry is simply a matter of automating and scaling the functions typically performed by an operator in an offline setting.
In developing its parenteral solutions, PTI has always focused on the sensitivity and reliability of the CCI test measurement. Without a reliable and accurate test measure, there is no true test method. PTI has developed two of the predominant container closure test methods for parenterals. Vacuum Decay dominates PTI’s patent portfolio with solutions that allow the test to achieve leak test sensitivity below 1 micron without the loss of sensitivity or reliability. PTI’s High Voltage Leak Detection (HVLDmc) achieves similar accolades, but the type of HVLD PTI has developed sets this measurement solution apart from others. PTI’s MicroCurrent HVLD does not lose capability with plastic containers and low conductivity liquid as with other HVLD solutions. Both HVLDmc and Vacuum Decay have been developed with the quality of the core measure in focus. Automating the operation of the system is the next generation of this technology’s presence in the pharmaceutical arena.
PTI’s Automated Solution
PTI set out with the simple objective of testing up to 1,000 containers per hour without any loss of sensitivity or reliability. The approach does not compromise test measurement reliability, and the act of automating the inspection relies on taking the appropriate time to properly handle and inspect costly final products. While the system is in-line, throughput is unlinked from the fill-finish process. This robotic automation accumulates a workload and processes the inspection with sharp focus on the output. The concept of high-speed on-line systems operating at the same rate of a fill-finish machine puts speed at a priority and not quality. PTI decouples the operation of the inspection solution from the fill-finish system yielding multiple advantages.
Glassware that is filled, sealed and nested in a tray is optimal for automated robotic inspection. The nesting tubs are transported into the PTI inspection system, where a robot efficiently and carefully moves containers into the test stations where the product is tested. Unlike a purely mechanical handling solution, a robot is dynamic and can operate with greater care in fine element control. Cycle time is focused on two specific areas, container handling and the inspection test method. Doing so would provide the highest level of CCI assurance with a throughput of approximately 1,000 containers in under an hour.
An ideal process has no compromise and there are no trade-offs in achieving objectives. PTI’s robotic automated inspection platform provides best in class CCI testing with no compromise within the parenteral process. PTI’s technology provides the reliability and accuracy in test measurement, while the automation platform provides the flexibility needed to not compromise on quality. In the world of parenteral quality assurance, compromise is not an option.
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