ISO 11040
ISO 11040:2022 is an international standard that specifies the design, dimensions, materials, and performance requirements for prefilled syringes used in the pharmaceutical and healthcare industries. With the rapid expansion of injectable drug delivery systems and the growing need for patient safety, product integrity, and manufacturing efficiency, ISO 11040 serves as a critical compliance benchmark for pharmaceutical packaging and delivery systems.
At Quality Asia Certification, we offer ISO 11040:2022 certification to support manufacturers of prefilled syringes in demonstrating product quality, global compliance, and safety standards.
65% Cost Reduction
60% Sustainability
Customer Attraction
Increase Your Competitive Edge
What is ISO 11040?
ISO 11040:2022, titled “Prefilled syringes – Parts 1 to 8”, is a multipart standard developed by the International Organization for Standardization. It covers a range of requirements for:
- Materials and testing of glass barrels (Part 4)
- Design specifications for plunger stoppers (Part 5)
- Needle-based or needle-free syringe systems (Parts 6, 7, and 8)
- Compatibility with automated manufacturing and packaging equipment
The standard ensures that prefilled syringes are compatible with both manual and automated drug delivery, minimizing contamination risk, breakage, and usability issues.
Why is ISO 11040 important?
With the rise in self-administered drugs, chronic disease treatment, and biotechnology products, prefilled syringes have become a preferred solution across the medical industry. Achieving compliance with ISO 11040:2022 enables syringe manufacturers to meet:
- Global regulatory expectations
- Healthcare provider demands for safer drug delivery systems
- Compatibility with fill-finish and assembly lines
It also ensures alignment with European Pharmacopeia and US FDA expectations regarding device safety, container closure integrity, and usability.
What are the benefits of ISO 11040?
- Precision in Product Design: Maintains consistent quality in the dimensions and functioning of syringes.
- Material Safety Assurance: Ensures compatibility and non-reactivity with a range of injectable formulations.
- Improved Sterility & Shelf Life: Reduces the risk of microbial contamination and supports longer shelf life.
- Enhanced Patient Experience: Enables ease of use, accurate dosing, and minimized needle-stick injuries.
- Interchangeability Across Platforms: Standardization supports compatibility with multiple drug delivery devices.
What kind of businesses can benefit from ISO 11040?
Obtaining ISO 11040:2022 certification from Quality Asia Certification enhances your operational credibility and brand value. The key business advantages include:
✅ Access to Global Markets – ISO 11040 compliance is often a prerequisite for international tenders and exports.
✅ Reduced Product Recalls – Minimizes compliance failures and technical inconsistencies.
✅ Increased Stakeholder Trust – Demonstrates your commitment to safety, quality, and global regulatory alignment.
✅ Competitive Advantage – Strengthens your market positioning in a rapidly growing drug delivery segment.
✅ Streamlined Manufacturing – Ensures compatibility with high-speed automated filling and inspection systems.
✅ Faster Regulatory Approvals – Aligns with FDA, EMA, and WHO prequalification guidelines.
Top Tips on making ISO 9001 effective for you.
#1
Top management commitment while practicing and accomplishing the standard is the key to success.
#2
Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.
#3
Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.
#4
Review systems, policies, processes, and procedures for a smooth working of QMS.
#5
Speaking to customers & suppliers while getting feedback & working on improvements.
#6
Training staff carrying out the internal audits with the opportunity for improvement.
#7
Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.
#8
Ensure continuous improvement by regularly reviewing and updating your quality management practices.
#9
Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.
Why QualityAsia?
QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:
Initial Certification – Stage 1 (Preparatory Phase)
- Thorough documented information review.
- Exchange of information with staff through online or onsite presence.
- Identification of key performances, processes & objectives as per the standard requisites.
- Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.
Initial Certification – Stage 2 (On-site Audit)
- Measurement, reporting & reviewing the performances against key performances objectives.
- Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
- Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
- Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.
Surveillance & Certification Renewal
Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.
