In the fast-moving world of drug manufacturing, contract development and manufacturing organizations (CDMOs) face tight timelines, diverse client needs, and ever-shifting regulatory expectations. Selecting the right equipment and vendors is key for every step and starts with doing your research. Aseptic filling is no exception. With both gloved and gloveless isolator options available, it’s essential to understand what truly sets the equipment and provider apart. To help you make the right decision for your needs, we have compiled a checklist of essential questions to ask.
1. What is your install base—especially at CDMOs—and where are your instruments located?
Understanding where and how a provider’s systems are deployed offers valuable insight into their experience and reliability. Ask for examples across geographies and modalities that are most relevant to your operations
2. What types of clinical and commercial products are filled with your systems?
Look for versatility. Can the system handle the variety of molecules your clients will want to fill – from traditional biologics to sensitive, high-value therapies? A wide range of supported modalities—such as the ones shown in Figure 1—signals flexibility and goes a long way towards future-proofing your aseptic filling operations.
Fig 1. Some of the many therapeutic modalities filled by Cytiva aseptic filling workcells.
3. Which regulatory agencies have approved products filled with your systems?
Regulatory confidence is critical. Ask for proof of drug approvals from agencies most relevant to your clients. The SA25 and Microcell™ workcells from Cytiva, for example, have been used in GMP-certified facilities across Europe and North America, including recent approvals under the updated EU Annex 1. Workcells have also been used to fill commercial products approved by the US FDA, Health Canada, Pharmaceutical Inspection Co-operation Scheme (PIC/S), National Medical Products Administration (NMPA), and a growing number of other agencies around the world.
4. How quickly can I get my system operational, validated, and inspection-ready?
Speed to GMP readiness is a major differentiator. At Cytiva, standardized gloveless isolators have helped CDMOs like White Raven and NorthX Biologics achieve GMP certification in up to 18 months (see Fig 2).
Fig 2. Timelines for two European CDMOs to quickly obtain GMP certifications aligned with the revised Annex 1 principles. See full infographic.
5. How are your systems compatible with regulatory guidelines, such as the updates to Annex 1?
Annex 1 emphasizes contamination control, risk mitigation, and quality by design. For example, aseptic filling workcells from Cytiva are designed with the following features that directly support Annex 1 principles and reduce the regulatory burden on CDMOs:
- Eliminate operator intervention in critical zones
- Use presterilized, ready-to-use components
- Employ validated, automated decontamination cycles
- Maintain unidirectional airflow and first air protection
- Offer the option to integrate real-time environmental monitoring (EM)
Specifically, the SA25 and Microcell™ workcells are designed from the ground up to align with the latest regulatory expectations, including the 2022 updates to EU GMP Annex 1: Manufacture of sterile medicinal products. These systems embody the principles of quality risk management (QRM) and quality by design (QbD), which are central to Annex 1’s guidance on minimizing contamination risk.
6. What support will I receive when I purchase your system?
Ask what training you will get, how it will be delivered, and what ongoing resources will be available. Clarify what’s included in installation support, as well as factory acceptance testing (FAT) and site acceptance testing (SAT). Look for access to other users and support that extends well beyond go-live. Cytiva, for instance, offers a user group community to share insights and troubleshoot challenges in a collaborative way.
7. What services do you offer to help me get through qualification, validation, and regulatory inspections smoothly?
Set yourself up for success with an offering that encompasses your needs. Qualification services can boost your speed to GMP readiness, and regulatory consulting can help you navigate a complex and dynamic landscape. Keeping your system running optimally is a must – equipment services can support you there.
Explore our aseptic filling services.
8. What’s the value of standardization?
Your user requirement specification (URS)—and those your clients may have—should guide the conversation. Ask about container types and sizes, fill volumes and batch sizes, throughput and line speed, infrastructure and utility requirements, and lead times. You will want to ensure a good match.
Check Microcell™ vial filler features.
Check SA25 aseptic filling workcell features.
9. What environmental monitoring (EM) technologies are compatible?
Annex 1 requires robust EM strategies and recommends moving toward rapid microbial methods that use continuous monitoring. If you’re looking to modernize—now or in the future—be sure the isolator you choose is compatible. Cytiva workcells offer the choice of traditional or more advanced methods. The BioTrak™ Real-Time Viable Particle Counter from TSI integrates seamlessly with the SA25 aseptic workcell to offer continuous, real-time monitoring of both viable and nonviable particles. This allows immediate action if needed and reduces potential batch loss.
Navigate your path to success
As a CDMO, you need more than a piece of equipment – you need a collaborator who understands the regulatory landscape, supports standardization, and helps derisk the investment. Whether you're building a greenfield facility or retrofitting a brownfield site, the right isolator provider should help you move fast, stay compliant, and serve your clients with confidence.
As Scott Harper, Director of Global Sales for Aseptic Filling at Cytiva, puts it: “Every conversation is different. I always ask upfront what the customer wants to know – there’s no value in a one-size-fits-all presentation. It should be a dialogue, not a monologue.”
Explore other relevant articles
- Key topics and trends in aseptic filling
- CDMO uses robotic gloveless isolator for advanced therapeutics
- Economic advantage of robotic gloveless pharmaceutical isolators
- How robotic isolator technology aligns to Annex 1 principles
- Why choose robotic processing for small batch aseptic filling
- Biofluorescent particle counters are gaining momentum