The gowning room is silent except for the sound of gloves snapping into place. An operator checks their donned PPE in the mirror to make sure there are no gaps causing a risk of contamination and takes a final breath before entering the aseptic core. One shortcut in donning, one item of PPE out of place and not providing the right seal and protection, and the entire batch could be lost.
This scene plays out daily in sterile pharmaceutical manufacturing, and it's exactly what regulators continue to focus on two years after the revised EU GMP ANNEX 1 came into force. Despite widespread training and updated SOPs, personnel remain the #1 contamination risk in aseptic environments (Annex 1, Section 7).
The real question is clear: Is your Contamination Control Strategy (CCS) a living system driving daily decisions, or just a static document in a binder?
The stakes, two years on
For different roles across sterile manufacturing, the risks of a weak CCS are still painfully real:
- Validation Engineer – repeated re-validation after excursions wastes valuable time and budget.
- QA Manager – incomplete environmental monitoring data raises audit risk.
- Procurement Manager – inconsistent supplier documentation complicates compliance and adds risk.
- EHS & Safety Manager – poorly designed PPE undermines both safety and operator adherence.
No matter the role, gaps in contamination control threaten compliance, productivity, and patient safety.
The critical gap: why your contamination control strategy is still vulnerable
Regulatory inspections since the release of Annex 1 continue to surface the same issues, proving that the CCS is failing to operate as a cohesive system:
- Human presence remains the number one contamination source. Legacy aseptic lines that allow operator intervention create the highest risks.
- Environmental monitoring is inconsistent. Some facilities under-sample in ISO 5 and 7 zones, or fail to trend and investigate excursions.
- Operator illness is overlooked. Cases were found where sterility test positives were dismissed because staff were unwell, without proper root cause analysis.
- CCS is static, not a system. Most critically, many facilities treat the CCS as a static, paper document, failing to integrate it as a living system tied to deviations, CAPA, and Change Control: contravening the requirement that the CCS " should be actively updated and should drive continuous improvement... " (Annex 1, Section 2.4).
These findings underscore one truth: having Annex 1 on paper is not enough. Execution matters.
How Ansell aligns PPE solutions with your CCS objectives
Instead of viewing PPE as a product requirement, Annex 1 requires you to view it as a strategic control measure. Ansell's solutions address compliance across three critical functional areas:
1. Assuring Audit Readiness and Validation (For QA & Validation Engineers)
For the QA Manager and Validation Engineer, Annex 1 (Paras 5.17, 7.12) raises the expectations for PPE suppliers by emphasising the need for validated, audit-ready documentation that supports contamination control effectiveness. The core compliance challenge lies not only in the quality of the PPE products but critically in the comprehensive validation packs that prove supplier products consistently meet sterility and performance standards, facilitating supplier qualification and regulatory inspections.
- Supplier Validation (Sections 5.17, 7.12):
A frequent operational gap noted during inspections is the lack of complete, auditable data required for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of PPE.
Ansell addresses this by providing thorough Validation Packs that include Certificates of Conformity, sterilisation (irradiation or ethylene oxide) reports, sterility certificates, and traceability documentation that directly satisfy Annex 1 supplier requirements. This streamlines the validation efforts and audit readiness for validation engineers.
- Environmental Monitoring (Section 9):
Reliable environmental monitoring depends on consistent, high-quality sampling materials. Ansell’s sterile gloves are manufactured to strict standards with low Acceptable Quality Limits (AQL), ensuring dependable sampling results.
This strengthens the Contamination Control Strategy by reducing the occurrence of false positives and unnecessary corrective actions, providing QA Managers with confident environmental trend analyses.
Ensure you select the right PPE standard: Clean & Sterile Cleanroom Gloves vs. Sterile Medical Gloves: Key Differences Explained.
2. Optimising operator performance and safety (for production & EHS / safety managers)
Personnel remain the greatest source of contamination, yet compliance can suffer if PPE is uncomfortable or difficult to use. Production and EHS/Safety teams require solutions that maximise sterility assurance while minimising human error and operator fatigue, —both critical for consistent gowning and aseptic practices.
- Annex 1 mandates that protective garments must cover the full length of arms and legs, be sterilised, and minimise particle shedding and contamination risk. Operators are frequently cited for exposed skin around wrists and temples caused by shifting garments or short gloves. Ansell addresses this through BioClean-D™ and Kimtech™ sterile coveralls, hoods, and BioClean™ Clearview goggles, ensuring no exposed skin. Extended 400mm glove options eliminate the wrist-cuff junction gap, a frequent contamination pathway in aseptic areas. For a deep dive into extended protection, see BioClean 73-425 400mm Neoprene Cleanroom Gloves Designed for Enhanced Forearm Protection.
- Personnel Training/Health (Section 7.5, 7.7): EHS / Safety Managers benefit from lightweight, ergonomic PPE which helps reduce operator fatigue and the risk of dermatitis, supporting a stronger safety culture and better adherence to aseptic procedures. Effective training on aseptic gowning and PPE use, as urged by Annex 1, enhances compliance and risk reduction.
- Barrier Technology (Section 4.10, 5.18): Sterile nitrile sleeve/glove systems and isolator gloves offer validated sterile barriers for Restricted Access Barrier Systems (RABS) operations, reducing direct operator-product contact and improving process control on legacy aseptic lines.
- For more on how PPE choices impact both compliance and operator wellbeing, explore The Benefits of Accelerator-Free Nitrile Gloves.
3. Controlling Risk and Supply Chain Resilience (For Procurement & Change Control)
The role of the Procurement Manager extends beyond cost control to encompass risk mitigation, resilience, and sustainability, aligned with Annex 1’s contamination control imperatives.
- Aseptic Donning (Section 7.11): Annex 1 requires gowning processes designed to minimise contamination risks. Multi-package gowning systems increase touchpoints and error risk. Ansell’s sterile garments are folded and packaged using validated aseptic donning methodologies to reduce contamination risk. Visual guides and comprehensive training resources ensure operators maintain consistent, compliant aseptic gowning practices. Learn more in our blog on aseptic donning best practices.
- Sustainability/ESR: Ansell’s Sterile Garment Kits and SMART Pack improve efficiency while supporting sustainability targets. SMART Pack reduces plastic bag use by nearly 50%, lowers CO₂ emissions, and uses fully recyclable materials (where facilities exist). As highlighted in our Sustainable Packaging Innovation for Cleanrooms blog, these innovations also align with EU packaging directives - helping Procurement Managers meet compliance, cost, and ESG goals simultaneously.
- Supply Chain Continuity (Section 3.1): Ansell’s global manufacturing and distribution network assures supply resilience and end-to-end supplier traceability. This simplifies change control processes for procurement and quality teams, even amid market disruptions, ensuring uninterrupted access to validated PPE.
For practical guidance on glove-related contamination control, see The Role of Double Donning in Contamination Control and Safety.
Two years on: where the market still struggles
Despite Annex 1’s clarity, challenges persist:
- Sterility assurance remains the top cause of pharmaceutical recalls, according to multiple regulatory analyses, validating the focus on risk management.
- CCS documents are often static and not tied to real deviations or CAPA.
- Environmental monitoring remains manual and reactive.
- Validation packs are incomplete from many suppliers, leaving QA exposed.
These gaps show that success isn’t just about knowing Annex 1, it’s about aligning PPE, training, monitoring, and documentation with the regulation in practice.
