US4211015A — Method and apparatus for making novel particulate…

Claim 1

Independent Claim 90 words

A method for producing dry particles, of which about 1 to 6% by weight are larger than 12 Mesh, from a liquid feedstock containing water and a biologically active substance selected from the group of antibodies, pharmaceuticals, bacteria, viruses and human body fluids, comprising providing a bath of liquid freezant at a temperature 0° C. in communication with a gaseous zone, passing a continuous stream of said feedstock through said zone and into an orderly, unidirectional flow of said freezant, recovering frozen pellets of said feedstock and lyophilizing said pellets.

Claim 2

Independent Claim 90 words

A method for producing dry particles, of which about 1 to 6% by weight are larger than 12 Mesh, from a liquid feedstock containing water and a biologically active substance selected from the group of antibodies, pharmaceuticals, bacteria, viruses and human body fluids, comprising providing a bath of liquid freezant at a temperature 0° C. in communication with a gaseous zone, passing a continuous stream of said feedstock through said zone and into an orderly, unidirectional flow of said freezant, recovering frozen pellets of said feedstock and lyophilizing said pellets.

Claim 3

Dependent Claim 17 words

The method of claim 1 wherein the continuous stream has the configuration of a substantially uniform cylinder.

Claim 4

Dependent Claim 11 words

The method of claim 1 wherein the substance is a pharmaceutical.

Claim 5

Dependent Claim 26 words

The method of claim 1 wherein the feedstock contains from about 4 gram percent to about 30 gram percent of solids with the remainder being water.

Claim 6

Independent Claim 52 words

A method for producing a quality control material, comprising passing a continuous stream of said material through a gaseous zone and into a freezant liquid to form frozen particles of said material, recovering said lyophilizing the particles, filling a predetermined mass of the particles into a container and hermetically sealing said container.

Claim 7

Independent Claim 52 words

A method for producing a quality control material, comprising passing a continuous stream of said material through a gaseous zone and into a freezant liquid to form frozen particles of said material, recovering said lyophilizing the particles, filling a predetermined mass of the particles into a container and hermetically sealing said container.

Claim 8

Independent Claim 153 words

A method for producing frozen particles of quality control material from a human blood component having a solids content of about 4 gram percent to about 30 gram percent, which comprises forming said component into a substantially continuous stream by passing it through an about 540/10,000 to about 95/10,000 inch orifice at a pressure of about 3 psig to about 15 psig, directing said stream through a gaseous zone disposed between said orifice and a moving surface of a boiling halocarbon freezant moving at a rate relative to said stream of about 2.5 to about 8 feet per second and into the surface of said freezant, the distance between said orifice and said surface of freezant being about 1 to about 5 centimeters, whereby said component enters said freezant and is frozen into particles at least about 75% by weight of which are, after lyophilization, in the 12 to 20 mesh size range.

Claim 9

Independent Claim 153 words

A method for producing frozen particles of quality control material from a human blood component having a solids content of about 4 gram percent to about 30 gram percent, which comprises forming said component into a substantially continuous stream by passing it through an about 540/10,000 to about 95/10,000 inch orifice at a pressure of about 3 psig to about 15 psig, directing said stream through a gaseous zone disposed between said orifice and a moving surface of a boiling halocarbon freezant moving at a rate relative to said stream of about 2.5 to about 8 feet per second and into the surface of said freezant, the distance between said orifice and said surface of freezant being about 1 to about 5 centimeters, whereby said component enters said freezant and is frozen into particles at least about 75% by weight of which are, after lyophilization, in the 12 to 20 mesh size range.

Claim 10

Dependent Claim 51 words

The method of claim 6 wherein the pressure is about 7 psig, the freezant surface moves at about 4.7 ft./sec., the distance between said orifice and said freezant surface is about 2 cm., the solids content of said component is about 11 gram percent, and said orifice is about 195/10,000 inch.

Claim 11

Dependent Claim 23 words

The method of claim 7 wherein at least about 87% by weight of said lyophilized particles are in the 12-20 mesh size range.

Claim 12

Independent Claim 112 words

A method for improving the lot size and lot uniformity of a lyophilized biologically active substance which comprises the steps of (1) preparing a first lot of said substance by (a) passing said substance into a moving liquid freezant to thereby form frozen particles of said substance; and (b) lyophilizing said frozen particles to produce lyophilized particles; (2) preparing one or more additional lots of said substance in the same manner as said first lot was prepared; (3) mixing the lyophilized particles of said first lot and said one or more additional lots; (4) dispensing the blend of lots produced in step (3) above into suitable containers; and (5) sealing said containers.

Claim 13

Independent Claim 112 words

A method for improving the lot size and lot uniformity of a lyophilized biologically active substance which comprises the steps of (1) preparing a first lot of said substance by (a) passing said substance into a moving liquid freezant to thereby form frozen particles of said substance; and (b) lyophilizing said frozen particles to produce lyophilized particles; (2) preparing one or more additional lots of said substance in the same manner as said first lot was prepared; (3) mixing the lyophilized particles of said first lot and said one or more additional lots; (4) dispensing the blend of lots produced in step (3) above into suitable containers; and (5) sealing said containers.

Claim 14

Dependent Claim 14 words

The method of claim 9 wherein the lots are not vacuum dried after lyophilization.

Claim 15

Dependent Claim 15 words

The method of claim 9 wherein the lyophilized particles are not reconstituted before being mixed.

Claim 16

Dependent Claim 14 words

The method of claim 9 wherein the lots have substantially the same moisture content.

Claim 17

Dependent Claim 56 words

The method of claim 9 wherein about 75 to 100% by weight of the particles in (a) said first lot, (b) said one or more additional lots, or (c) the lot produced by mixing (a) and (b) are in the 12-20 mesh size range and the rest are in a size range other than 12-20 mesh.

Claim 18

Dependent Claim 22 words

The method of claim 9 wherein about 87 to 100% by weight of said particles are in the 12-20 mesh size range.

Claim 19

Dependent Claim 11 words

The method of claim 9 wherein the substance is defibrinated plasma.

Claim 20

Independent Claim 59 words

A method for producing a sealed container of lyophilized feedstock particles, comprising concentrating the solids in said feedstock, passing said concentrated feedstock in a continuous stream through a gaseous zone and into a freezant liquid, recovering said particles of feedstock from said freezant liquid, lyophilizing said particles, filling a container with the lyophilized particles, and hermetically sealing said container.

Claim 21

Independent Claim 59 words

A method for producing a sealed container of lyophilized feedstock particles, comprising concentrating the solids in said feedstock, passing said concentrated feedstock in a continuous stream through a gaseous zone and into a freezant liquid, recovering said particles of feedstock from said freezant liquid, lyophilizing said particles, filling a container with the lyophilized particles, and hermetically sealing said container.

Claim 22

Dependent Claim 12 words

The method of claim 16 wherein the solids are concentrated by ultrafiltration.

Claim 23

Dependent Claim 11 words

The method of claim 16 wherein the solids concentrated are proteins.

Claim 24

Dependent Claim 15 words

The method of claim 18 wherein the protein is concentrated to about 12 gram percent.

Claim 25

Dependent Claim 13 words

The method of claim 16 wherein the feedstock is a biologically active substance.

Claim 26

Independent Claim 63 words

A method for producing a sealed container of lyophilized particulate control material from human blood plasma, comprising concentrating the protein in said plasma, passing said concentrated plasma in a continuous stream through a gaseous zone and into a freezant liquid, recovering frozen plasma particles from said freezant liquid, lyophilizing said particles, filling a container with the lyophilized particles, and hermetically sealing said container.

Claim 27

Independent Claim 63 words

A method for producing a sealed container of lyophilized particulate control material from human blood plasma, comprising concentrating the protein in said plasma, passing said concentrated plasma in a continuous stream through a gaseous zone and into a freezant liquid, recovering frozen plasma particles from said freezant liquid, lyophilizing said particles, filling a container with the lyophilized particles, and hermetically sealing said container.

Claim 28

Dependent Claim 28 words

The method of claim 21 wherein two or more lots of said lyophilized plasma particles are mixed and the containers are filled with the resulting mixture of lots.

Claim 29

Dependent Claim 19 words

The method of claim 21 including the additional step of assaying at least one constituent of said control material.

Claim 30

Dependent Claim 60 words

In a method for producing frozen particles of blood plasma or serum wherein said plasma or serum is passed through an orifice and into a liquid freezant at a temperature below the freezing point of said plasma or serum without said orifice contacting said freezant, the improvement comprising passing a continuous stream of said plasma or serum into said freezant.

Claim 31

Dependent Claim 60 words

In a method for producing frozen particles of blood plasma or serum wherein said plasma or serum is passed through an orifice and into a liquid freezant at a temperature below the freezing point of said plasma or serum without said orifice contacting said freezant, the improvement comprising passing a continuous stream of said plasma or serum into said freezant.

Claim 32

Independent Claim 42 words

A method which comprises passing a continuous stream of a blood component solution through a gaseous zone and into a freezant liquid at a temperature below the freezing point of said component whereby frozen pellets of said blood component solution are formed.

Claim 33

Independent Claim 42 words

A method which comprises passing a continuous stream of a blood component solution through a gaseous zone and into a freezant liquid at a temperature below the freezing point of said component whereby frozen pellets of said blood component solution are formed.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1983-07-08	1984-01-07	1984-07-08	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1987-07-08	1988-01-07	1988-07-08	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	1991-07-08	1992-01-07	1992-07-08	$7700.00	Window Closed / Lapsed

Method and apparatus for making novel particulate compositions

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