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Solutions for radiopharma

Radiopharmaceutical manufacturing must protect the patient from contamination while protecting operators and the environment from the radioactive product. This dual requirement changes the production architecture: containment, shielding, airflow direction and limited operator access become primary design drivers.

The product must be sterile,  its radioactivity must be contained.

The sterility route depends on the actual product: some radiopharmaceuticals are sterile-filtered and aseptically filled, while others can be filled, closed and terminally sterilized. The manufacturing environment must reflect the selected route and whether the sterile product is ever exposed.


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APPLICATION NUMBERS

Up to 700
vials/8-hour run production output 

2
vials/minute line-productivity 

≥98%
uptime sytem-efficiency 

Key advantages of Fedegari steam sterilization technology integrated into hot-cell containment for radiopharmaceutical production

STERILIZATION AS PART OF THE CONTAINMENT STRATEGY

For radiopharmaceuticals, terminal sterilization must address 3 inseparable constraints: required lethality, product stability and radiological containment.

Together, these constraints define both the thermal cycle and the autoclave integration. Its configuration and interfaces are engineered around the hot-cell layout, shielding, pressure relationships, access restrictions and radioactive-contamination risks.

The result is more than a thermal cycle: a repeatable, validation-ready process integrated into the containment architecture, achieving sterility without introducing unnecessary operator exposure, avoidable time loss or a weak point between contained production and downstream operations.

RADIOPHARMACEUTICALS MANUFACTURING

Radiopharmaceuticals manufacturing
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FEDEGARI SOLUTIONS FOR RADIOPHARMACEUTICALS

Small Molecules
Medical Devices
Primary Packaging
Cosmetics

TERMINAL STERILIZATION OF FILLED CONTAINERS

Achieving sterility without weakening radiological containment.

Cycle development starts from the filled container and the customer-defined acceptance criteria. Load patterns, temperature distribution, heat penetration, lethality and chamber pressure are defined around formulation stability, radiochemical quality and container-closure integrity.

The autoclave configuration and its interfaces are engineered around shielding, pressure relationships, operating access and radioactive-contamination risks, integrating terminal sterilization into the facility’s containment strategy and the time available between filling and release.

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ATMP - genes, tissues or cells
Biotech
Small Molecules
Medical Devices
Primary Packaging
OSD
R&D and LAB centers
Cosmetics

GLASS VIALS

The rapid growth of biologics, nanoparticle-based medicines and Advanced Therapy Medicinal Products (ATMPs) is redefining the relationship between pharmaceutical formulations and primary packaging.
Interactions between proteins such as insulin, nanoparticles and container surfaces are well-recognised phenomena that can influence product stability, efficacy and patient safety. As these therapies become increasingly sensitive, material compatibility can no longer be considered an intrinsic property of the container alone.

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ATMP - genes, tissues or cells
Biotech
Small Molecules
Medical Devices
Primary Packaging
OSD
R&D and LAB centers
Cosmetics

GLASS VIALS IN NEST

When manufacturers seek to move away from EtO towards a method that reduces toxic-residue concerns and the potential burden on patients, workers and the environment, selecting an alternative sterilant is only the beginning.
This is particularly true for the low-temperature sterilization of RTU glass vials in their complete packaging configuration. The sterilant must pass through the outer transport box, multiple porous barriers and enclosed packaging interfaces before reaching the internal vial surfaces. The same structure must then release residual sterilant within an acceptable aeration time.

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ATMP - genes, tissues or cells
Biotech
Small Molecules
Medical Devices
Primary Packaging
OSD
R&D and LAB centers
Cosmetics

PRE-FILLED SYRINGES

A pre-filled syringe is a hermetically sealed container with a movable plunger. During thermal sterilization, the liquid expands, part of it vaporizes, dissolved gases are released and the gas already present in the headspace increases in pressure.
An aqueous solution expands by approximately 6% when heated from ambient temperature to 121°C, while the volume of a glass syringe increases by only about 1%.

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PRESSURE CONTROL
In saturated steam sterilization, pressure governs steam conditions. Controlling pressure supports temperature uniformity and repeatable process behavior. 
±0.5°C UNIFORMITY
Temperature standard deviation is a key indicator of process behavior. The tighter the deviation, the greater the stability and repeatability across the entire load. 
DRY-LOADS
Critical components 
emerge sterile, dry and ready for immediate use. 
CANISTER PROVEN
We support advanced  canister-based transfer strategies while preserving filter integrity, drying performance and sterile transfer conditions.

FREQUENTLY ASKED QUESTIONS

Does radioactivity remove the need for contamination control?

No. Radioactivity cannot be treated as a universal microbial-control mechanism. Radiopharmaceuticals intended for parenteral administration must still meet the applicable sterility requirements. The process must therefore protect the product from contamination while simultaneously protecting operators and the environment from radiation.

When can a radiopharmaceutical be terminally sterilized?

Terminal sterilization is applicable when the formulation and container-closure system tolerate the required thermal process without unacceptable changes in product quality, activity, radiochemical purity or package integrity. The available time between preparation, filling, sterilization, release and administration must also be considered.

Is a hot-cell the same as an isolator?

No. A hot-cell is a shielded workstation for manufacturing and handling radioactive materials and is not necessarily designed as an isolator. Its primary function is radiological protection. The contamination-control conditions required inside it depend on the process and whether sterile product or critical surfaces are exposed.

How is the autoclave integrated into the containment strategy?

The integration assessment considers hot-cell layout, shielding, pressure relationships, door interfaces and operator access. It should also address abnormal events such as container leakage or breakage, including potential chamber contamination, liquid collection, exhaust management and the conditions required for safe cleaning and maintenance.

How is the terminal sterilization process validated?

Validation includes defined minimum and maximum loads, temperature distribution, heat penetration, lethality and critical cycle parameters. The process must also be assessed against the actual formulation and container-closure system, including relevant acceptance criteria for product quality, activity, radiochemical purity and package integrity.

What environmental classification is required?

The required classification depends on the operation and must be supported by risk assessment. Grade C may be suitable for closed operations such as synthesis, purification and online sterile filtration. Aseptic activities involving exposed sterile product or critical surfaces must be performed under Grade A conditions.

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