Container for lyophilizing biological products

A system for lyophilizing biological solutions in a lyophilization chamber, said chamber having a shelf to receive said system while freezing and lyophilizing said solution, said system comprising:

• a) a disposable container, said container having;
• (i) a tray having a solution side compatible with said solution, said tray defining
• (1) a floor having a first inside periphery, an inside surface contacting said solution, and an underside surface contacting said shelf, said floor formed of a pliable material that easily conforms to said shelf;
• (2) a vertical wall extending upward along said first inside periphery, said wall having a second upper periphery, and a landing extending from said upper periphery;
• (ii) a roof having a third inside periphery, said roof incorporating a hydrophobic membrane, said membrane providing vapor communication with said chamber while retaining said solution within said chamber, said floor, vertical walls and roof joined to form a solution sealed product chamber for containing said solution;
• (iii) at least one port in fluid communication with said solution chamber said port used to introduce into said chamber and or remove from said chamber said solution;
• b) a rigid supporting tray adapted to be placed on said lyophilization shelf, said supporting tray used to support and facilitate handling of said lyophilization container prior to and during a lyophilization process;
• wherein said floor of said container is sufficiently pliable that said floor conforms, by the weight of said solution in the container, to the surface of said lyophilization shelf thereby assuring the intimate contact between the two surfaces necessary for the most efficient thermal transfer between said shelf and said solution via said floor.

A container for desiccating a biological solution in a desiccating chamber, said chamber having a shelf to receive said container while drying said solution, said container comprising

• a) a tray having a solution side compatible with said solution, said tray defining;
• (i) a floor having a first inside periphery, an inside surface contacting said solution, and an underside surface contacting said shelf, said floor formed of a pliable material that easily conforms to said shelf;
• (ii) a vertical wall extending upward along said first inside periphery, said wall having a second upper periphery and a landing extending from said upper periphery;
• b) a roof having a third inside periphery, said roof incorporating a hydrophobic membrane, said membrane providing vapor communication with said chamber while retaining said solution within said chamber, said floor, vertical walls and roofjoined to form a solution sealed product chamber for containing said solution;
• c) at least one port in fluid communication with said solution chamber said port used to introduce into said chamber and or remove from said chamber said solution;
• d) wherein said floor is sufficiently pliable that said floor conforms, by the weight of said solution in the container, to the surface of said shelf thereby assuring the intimate contact between the two surfaces necessary for the most efficient thermal transfer between said shelf and said solution via said floor.

A container for lyophilizing a biological solution in a lyophilization chamber, said chamber having a shelf to receive said container while freezing and lyophilizing said solution, said container comprising

• a) a tray having a solution side compatible with said solution, said tray defining;
• i) a floor having a first inside periphery, an inside surface contacting said solution, and an underside surface contacting said shelf;
• ii) a vertical wall extending upward along said first inside periphery, said wall having a second upper periphery;
• b) a roof having a third inside periphery, said roof incorporating a hydrophobic membrane having a fourth outside periphery that is at least as large as said third inside periphery of said roof, said membrane providing vapor communication with said chamber while retaining said solution within said chamber, said floor, vertical walls and roofjoined to form a solution sealed product chamber for containing said solution;
• b) at least one port in fluid communication with said solution chamber said port used to introduce into said chamber and or remove from said chamber said solution;
• c) a thermal plate placed between said underside surface of said floor of said container and said shelf of said lyophilization chamber;
• wherein said thermal plate assures intimate thermal contact between said floor of said container and said shelf of said lyophilization chamber.

A container for lyophilizing a biological solution in a lyophilization chamber, said chamber having a shelf to receive said container while freezing and lyophilizing said solution, said container comprising

• a) a tray having a solution side compatible with said solution, said tray defining;
• i) a floor having a first inside periphery, an inside surface contacting said solution, and an underside surface contacting said shelf,
• ii) a vertical wall extending upward along said first inside periphery, said wall having a second upper periphery;
• b) a roof, said roof incorporating a hydrophobic membrane, said membrane providing a vapor path with said chamber while retaining said solution within said chamber, said floor, vertical walls and roof joined to form a solution sealed product chamber for containing said solution;
• c) at least one port in fluid communication with said solution chamber said port used to introduce into said chamber and or remove from said chamber said solution;
• d) a mating flange having an opening said opening, having a third periphery, said opening corresponding to said hydrophobic membrane;
• wherein when said matching flange tops said container, the weight of said flange providing an additional force that enhances the thermal contact between said underside of said floor and said shelf of said lyophilizer without obstructing said vapor path.

A container for lyophilizing a biological solution in a lyophilization chamber, said chamber having a shelf to receive said container while freezing and lyophilizing said solution, said container comprising

• a) a tray having a solution side compatible with said solution, said tray defining;
• i) a floor having a first inside periphery, an inside surface contacting said solution, and an underside surface contacting said shelf;
• ii) a vertical wall extending upward along said first inside periphery, said wall having a second upper periphery;
• b) a roof, said roof incorporating a hydrophobic membrane having a third outside periphery, said membrane providing vapor communication with said chamber while retaining said solution within said chamber, said floor, vertical walls and roofjoined to form a solution sealed product chamber for containing said solution;
• c) a removable, impermeable cover having a fourth outside periphery said fourth periphery being at least as large as said third inside periphery of said membrane;
• wherein said impermeable cover seals and protects said membrane.