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Crystal Closed Vial Technology

products-servicesAseptic Technologies S.A.
December 4th 2011

The Crystal® Closed Vial technology is a technology designed to improve the quality of aseptic filling of injectable products. It consists of two main elements: 1st is a vial with a stopper in place. This vial is clean and sterile hence ready-to-fill. 2nd the filling equipment is designed to process the Crystal® Closed Vials. The main filling steps are the vial filling after piercing the stopper, the stopper re-sealing by laser to restore the closure integrity and the capping. Besides these two main elements, a specific barrier system, the CVFS containment has been designed to ensure optimal quality when installed in ISO8 surrounding environment.

The key advantages of the Crystal® technology are:
• A better quality for the patient thanks to the container being permanently closed and the use of very resistant polymer materials. Therefore both risks of contamination and cracks are greatly reduced compared to open glass containers
• An easier solution for the pharmaceutical manufacturer thanks to the use of ready-to-fill containers. Therefore all unnecessary steps such as vial washing, depyrogenization in hot air tunnel, stopper washing and stopper sterilization are eliminated
• A preferred solution for end-users thanks to easy handling, opening, piercing and liquid collection processes.

These advantages in combination with better asepsis and resistance to shocks led 87% of 246 end-users interviewed to declare their preference for the Crystal® Closed Vials versus open glass vials.

Crystal® Ready-to-Fill Closed Vials
The Crystal® Closed Vials are made of 5 elements:
• A vial body to contain the liquid
• A stopper to ensure closure integrity
• A top ring which secure the assembly of the two previous elements
• A bottom ring (only on small vials) for vial stability
• A cap which protects to piercing area

The vial body is made of Cyclo-Olefin Co-polymer (COC), a polymer material with high transparency, high resistance to irradiation, high resistance to shocks and high barrier properties against water vapour transmission.

The stopper is made of TPE (Thermo Plastic Elastomer), an elastomer specifically designed to allow laser re-sealing. Both materials meet the requirements from FDA and EMA agencies for the pharmaceutical primary container.

The overall manufacturing procedure has 5 steps:
• Moulding of both vial body and stopper in an ISO5 clean room to ensure cleanliness
• Pick up by robots and immediate closing of the two elements in Class ISO5
• Final assembly of closed vial to a Class ISO8 with the addition of rings
• Packaging in polypropylene boxes and double wrapping in polyethylene bags
• Sterilization by gamma radiation (minimum of 25kGray).
Crystal® Ready-to-Fill Closed Vials are available in several formats and packaging. Nominal capacities range from 1 to 50ml and have space for overfill. Crystal® Closed Vials up to 2ml are manufactured using injection moulding while larger containers are made using injection blow moulding.
Amber vials (light sensitive) and oxygen-depleted closed vials are readily available for products sensitive to light or oxygen.

Crystal® Filling Lines
A range of equipment is designed to fill very small lots (stability batches, clinical batches for phase I and IIa, commercial batches for niche products) up to large scale batches (600 vials/minute). Each piece of equipment performs the three critical steps – filling, laser re-sealing and capping and all of them provide the same advantages in terms of safe and simple aseptic processing.

Laboratory Crystal® M1 Filling Station is designed to fill clinical and stability batches, research lots and commercial batches for niche products. In a single shift basis the Laboratory Crystal® M1 Filling Station can handle up to 2,000 vials with two manual operators. The Laboratory Crystal® M1 Filling Station is in full accordance with cGMP requirements and can be installed in multiple surrounding equipment such as safety laminar airflow cabinets, CVFS and isolators to ensure ISO5 environment in the filling area. Format change is very simple as the vial supporting base is the only format part and the station has the capability to process the entire size range of ready-to-fill Crystal® Closed Vials, from 1ml to 50ml. The Laboratory Crystal® M1 Filling Station is suitable for both liquid and for lyophilized products. The station requires only electricity for operation.

Laboratory Crystal® L1 Robot Line is designed to fill clinical and stability batches, research lots and commercial batches for niche products. In a single shift basis the Laboratory Crystal®L1 Robot Line can handle up to 5,000 vials, reaching a nominal capacity of up to 600 vials/hour. The equipment consists of a robot equipped with the three tools, needle, laser head and capping head. The vials supplied in racks are placed by the operator and the robot is launched to perform the three production steps. The Laboratory Crystal® L1 Robot Line is in full accordance with cGMP requirements and can be installed in multiple surrounding equipment such as CVFS and isolators to ensure ISO5 environment in the filling area. Format change is very simple as there is no format function, format change is based on program selection for the robot on the HMI of the equipment. The line has the capability to process the entire size range of ready-to-fill Crystal® Closed Vials, from 1ml to 50ml. The Laboratory Crystal® L1 Robot Line is suitable for both liquid and for lyophilized products. The line requires only electricity for operation and the size of the core equipment is limited to 1m².

The Production Crystal® Cx and Px Filling Lines are designed to fill medium to large scale batches. In a single shift basis the Production Crystal® Cx and Px Filling Lines can handle up to 40,000 and 80,000 vials, reaching a nominal capacity up to 100 and 200 vials/minute respectively. The equipment conveyor is based on a magnetic conveying system using small independent pucks. Each puck is presented to the three tools, needle, laser head and capping head. The loading of the vial is made according to the client requirement and equipment surrounding. Among various options are manual loading (recommended for ISO7 surrounding), automatic loading by robot (recommended for ISO8 environment) and manual loading with e-beam top surface sterilization (recommended for ISO8 surrounding). The Production Crystal® Cx and Px Filling Lines are in full accordance with cGMP requirements and can be installed in multiple surrounding equipment such as CVFS and isolators to ensure ISO5 environment in the filling area. Format change is very rapid as the format parts consists in the pucks (each changed within few seconds) and few guides. The line has the capability to process the entire size range of ready-to-fill Crystal® Closed Vials, from 1ml to 50ml. The Production Crystal® Cx Filling Line is suitable only for both liquid whereas Px line would be selected for liquid and lyophilized products. The line requires only electricity for operation and the size of the core equipment is limited to 10-11m² so a clean room of 40-60m² is largely sufficient for installation.

The Production Crystal® Pxx Filling Line is designed to fill very large scale batches. In a single shift basis the Production Crystal® Pxx Filling Line can handle up to 250,000 vials, reaching a nominal capacity up to 600 vials/minute. The loading of the vial is made according to the client requirement but manual loading with e-beam top surface sterilization (suitable for ISO8 surrounding) is strongly recommended to reach the expected productivity. The Production Crystal® Pxx Filling Line are in full accordance with cGMP requirements and has been designed to be surrounded by CVFS to ensure ISO5 environment in the filling area. Format change is feasible but it is recommended to design it for a single format as format change takes some time. The line has the capability to process the entire size range of ready-to-fill Crystal® Closed Vials, from 1ml to 50ml. The line requires only electricity and compressed air for operation and the size of the core equipment is limited to 44m² so a clean room of 100m² is sufficient for installation.

Closed Vial Filling System (CVFS)
CVFS containment has been designed for installation of a Closed Vial Filling Line in an ISO8 environment. The CVFS design has been created following a process of “quality of design” based on the fact that the Crystal® vial is permanently closed and acts as a mini-isolator by it-self. The CVFS is designed to provide a physical separation between operators and the aseptic processing area. This is achieved by building a rigid wall enclosure which remains permanently closed during all operations. To ensure the CVFS is permanently closed, each door is equipped with joints and an interlock to prevent any accidental opening. Air flow is delivered through HEPA filters and is evacuated by the open bottom maximizing laminarity of air-flow. During filling operations, operators must use glove ports to access the area and material entry is done through secured systems such as rapid transfer ports, VHP airlocks, e-beam or automatic loading systems. Equipment sanitization is achieved by manual wiping with sporicidal agents or overall gassing of the room (dry fog).

For more information or to discuss Crystal® Closed Vial Technology please contact us directly

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