Injectable & Sterile CDMOs: Lyophilization, Vials, PFS — What Buyers Must Verify Before RFQ

Introduction

Injectable manufacturing is a high-risk decision for companies to outsource to suppliers in the pharmaceutical industry. An organization's suppliers may be chosen based on their capacity and cost prior to an request for quotation (rfq) being issued; sometimes these decisions are made too early. In 2026, food and drug administration (fda) guidelines require companies to verify that all supplier manufacturing facilities for injectables have sterility assurance systems and appropriate filling technologies, inspection standards, and validation maturity before beginning commercial discussions.

This article focuses on requirements of all technical and operational components that must have been verified by potential sterile, lyophilized, vial, or prefilled syringe CDMOs prior to issuing an rfq to a supplier. (Also read: Injectable Manufacturing Partners: A Buyer’s Guide to Sterile, Lyophilized & Prefilled Syringe Suppliers)

Why Pre-RFQ verification important for Injectables

The importance of verifying technical and operational components of a sterile product prior to rfq issuance is that unlike oral dosage forms, injectables have little to no chance of recovering from failure once they are manufactured. One single occurrence of contamination, validation issues or incidents during inspection process may result in rejection of batched products, regulatory findings, and/or long-term disruption of supply. This process also enables companies to eliminate high-risk supplier partners early in the manufacturing process and issue an rfq only to those suppliers who are technically competent.
 

Sterility Assurance: The First Step, not just a checkbox

Sterility assurance is defined by a manufacturer's process and their practices rather than the results from final testing. Therefore, companies need to be certain that the contract manufacturer demonstrates a consistent effective delivery of the sterility process during all stages of the manufacturing process.

Key considerations include performance indicators, such as type of media used to manufacture the product, historical success rates of the media, methods used to manage the product's surroundings during production, gowning process adherence, maintenance of cleaning and sterilization processes, and methods for handling deviations from the plan. A CDMO that has explained the rationale behind why its sterility system works is typically more trustworthy than one that provides only documentation of its activities.
 

Filling technologies should match the Product's Risk Profile

For buyers, it is important to understand that while there are many types of filling systems available, not all are appropriate for every product. Additionally, it is critical for buyers to confirm what type of filling technology will be used on a regular basis by the supplier. Buyer needs to consider factors such as:

• Open vial filling technology: Though It offers flexibility, but due to the potential for increased risk of Human Intervention with Open Vial Filling Equipment, it may not be the best fit into a Buyers Risk-Product Matrix.

• Restricted Access Barrier System (RABS): Provides a balance between Control and Operator Flexibility.

• Isolator-based filling provides the highest sterility assurance, however, they are less capable of rapidly changing over due to long changeover times.

For Pre-fillable Syringe applications (PFS), Buyers also want to verify siliconization control processes, accuracy of plunger installation, handling of the needle, and monitoring of particulates. These critical areas are common points of failure.
 

Lyophilization Capability — Prefer Experience than Equipment

Simply because a manufacturer owns Freeze Dryers does not guarantee they possess expertise in Lyophilization. Buyers must confirm that suppliers have been manufacturing products that are Lyophilized, in addition to having development capabilities.

Buyers should also confirm suppliers are able to provide evidence of completed cycle development, maintained Thermal Mapping records, verified Product Load Pattern Validation, Condenser Capacity, and Fail-Recovery Procedures. The Majority of cosmetic defects, Moisture Variation, and Stability Failures can be directly related back to poor control of the Lyophilization process.
 

Visual Inspection / Acceptance Quality Level (AQL)

The area of Visual Inspection continues to be one of the most underestimated risk areas within the Injectable Manufacturing arena. Buyers must ensure they understand:

• What type of Inspection is performed: Manual, Semi-Automatic, or Automated
• Proper AQL Levels have been established along with Rejection Criteria
• Requalification periods, and the handling of false reject units
• Handling of false rejects and bias control procedures

If a Manufacturer has a weak Inspection system, it will result in defective units being introduced, or excessive good units being rejected, and in both instances an increase in cost and risk for the Buyer.
 

Validation Proof — Evidence Over Statements

Before RFQ, buyers should request proof of validation maturity, not summaries. This includes process validation approach, aseptic process simulation data, cleaning validation rationale, container-closure integrity testing (CCIT), and change-control history.

A CDMO that hesitates to share redacted validation evidence is often not RFQ-ready for high-risk injectables.
 

CDMO Regulatory Track Record & Inspection Results

Buyers purchasing injectable products must consider a potential injectable CDMO's recent successful inspections of the respective markets served. Buyers must inquire about the presence of critical observations made by various inspectors, including the number of repeat observations and the effectiveness of any corrective actions taken.

Any CDMO that has a history of numerous repeat observations for the aseptic environment or data integrity is likely to have very serious underlying quality issues.
 

Injectable CDMO Capacity, Availability, and Request for Quotation (RFQ) timing

Many RFQs are rejected because the buyer did not validate actual line availability and realistic slot availability. Before RFQs are issued, buyers need to confirm the CDMO can deliver product for pilot, launch, or scale volume production without significant overutilization or deprioritization of production slots.
 

Common Buyer Mistake: RFQ before Verification

Once RFQs are issued before there is technical verification of the CDMO's equipment and processes, the likely results are:

• Inaccurate pricing comparisons
• Ineffective or unnecessary audits, and
• Late cancellations of projects.

In injectables, verification must precede pricing discussions, not follow them.
 

Conclusion

The selection of an injectable CDMO in 2026 is principally a risk management decision. Buyers who validate the depth of a CDMO's assurance of sterility; the suitability of the filling line for the injectable product; the development of appropriate Acceptance Quality Limits (AQLs), and who validate through Documentation the equipment and processes for injectable production, can significantly reduce execution and regulatory driven risks. The best sourcing results occur when RFQs are sent only to OEMs with proper technical alignment and who can undergo an audit, as opposed to sending RFQs to the broadest possible vendor base.

Frequently Asked Questions(FAQs)

1. What should buyers verify before sending an RFQ to an injectable CDMO?

Before RFQ, buyers should verify sterility assurance systems, actual filling line technology, inspection and AQL practices, validation maturity, regulatory inspection history, and realistic capacity availability.

2. Is isolator filling always required for sterile injectables?

Not always. Isolators provide the highest sterility assurance, but well-controlled RABS systems can also be acceptable depending on product risk, batch size, and lifecycle stage. The key is consistent performance, not technology alone.

3. How can buyers assess real lyophilization capability?

Buyers should confirm commercial lyophilized product experience, validated cycles, thermal mapping data, and failure-handling procedures rather than relying on equipment lists alone.

4. Why are AQL and visual inspection systems critical?

Visual inspection is the last quality gate before release. Poorly defined AQL levels or weak inspector qualification can either allow defects to pass or cause excessive rejects, both of which create compliance and cost risk.

5. What validation documents should buyers expect before RFQ?

At a minimum, buyers should expect redacted examples of aseptic process simulations, cleaning validation rationale, CCIT strategy, and an overview of change-control practices to confirm validation maturity.