Sterile or specific pathogen free environment products

• US 5,858,793 A
• Filed: 10/30/1996
• Issued: 01/12/1999
• Est. Priority Date: 11/05/1992
• Status: Expired due to Fees

• Current Assignee: Hampshire Advisory and Technical Services Limited
• Original Assignee: Hampshire Advisory and Technical Services Limited
• Inventors: Wilson, Michael, Monro, Philip
• Primary Examiner(s): Spector, Lorraine
• Assistant Examiner(s): LAZAR WESLEY, ELIANE M
• Application Number:
  US08/741,314
• Time in Patent Office: 804 Days
• Field of Search: 436/63, 436/514, 436/175, 436/178, 210/650, 210/295, 210/649, 210/651, 435/325, 435/800, 435/962, 435/420, 47/59, 47/60, 47/61, 47/62, 47/58, 119/245, 119/259, 119/260, 604/82, 604/83, 604/92, 604/283, 604/905
• US Class Current: 436/63
• CPC Class Codes: C12M 37/02 Filters
• CPC Class Codes: C12M 37/04 Seals
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: Y10S 435/80 Elimination or reduction of contamination by undersired ferments, e.g. aseptic cultivation
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

Methods of maintaining or providing sterile or specific pathogen free environments are disclosed. The methods involve the use of semi-permeable membrane materials between the sterile or pathogen free environment and surrounding potentially hostile environments.

Claims

1. A method of testing a potentially infectious substance selected from the group consisting of blood, tissue, and other biological samples, said method comprising the steps of:

(a) placing the potentially infectious substance to be tested in a container of which at least a part of the container is formed of a semi-permeable membrane, the semi-permeable membrane having a molecular weight cut-off such that viruses and other potentially infectious organisms are retained within the container by virtue of having a molecular weight higher than the molecular weight cut-off;

(b) closing the container; and

(c) contacting the semi-permeable membrane with at least one reagent solution thereby allowing non-infectious components of said substance to pass through the membrane and react with the reagent solution, therefore allowing the test to be performed.

2. A method of testing as claimed in claim 1 further characterized by said container containing a predetermined volume of a substance to be tested, said substance being in contact via the semi-permeable membrane with a predetermined volume of said reagent solution.

3. A method of testing as claimed in claim 1 further characterized in that a plurality of said containers are tested in a common solution of test reagent, whereby a plurality of substances may be simultaneously tested without risk of cross contamination.

4. A method of testing a potentially infectious substance selected from the group consisting of blood, tissue, and other biological samples, said method comprising the steps of:

(a) placing the potentially infectious substance to be tested in a container of which at least a part of the container is formed of a semi-permeable membrane, the semi-permeable membrane having a molecular weight cut-off such that viruses and other potentially infectious organisms and toxins thereof are retained within the container by virtue of having a molecular weight higher than the molecular weight cut-off;

(b) closing the container; and

(c) contacting the semi-permeable membrane with at least one reagent solution thereby allowing non-infectious and non-toxic components of said substance to pass through the membrane and react with the reagent solution, therefore allowing the test to be performed.

5. A method of testing as claimed in claim 4 further characterized by said container containing a predetermined volume of a substance to be tested, said substance being in contact via the semi-permeable membrane with a predetermined volume of said reagent solution.

6. A method of testing as claimed in claim 4 further characterized in that a plurality of said containers are tested in a common solution of test reagent, whereby a plurality of substances may be simultaneously tested without risk of cross contamination.

7. A method of introducing a secondary substance in solution into a liquid specific pathogen free (SPF) environment, said SPF environment containing living tissue selected from the group consisting of plant seeds, plant seedlings, plant cuttings, plants, root system of plant seedlings, root systems of plant cuttings, root systems of plants, fish eggs, larval forms of fish and fish, said method comprising the steps of interfacing the SPF environment with a surrounding environment by means of a semi-permeable membrane and introducing said solution on an opposed side of the membrane to the SPF environment whereby the secondary substance in solution may pass through the membrane into the SPF environment while contaminants of higher molecular weight are excluded.

8. A method of treating an in-vitro culture comprising the steps of enclosing cell(s) to be cultured in a sealable receptacle which has at least a portion comprising a semi-permeable membrane, said membrane having a molecular weight cut off such that viruses and other potentially infectious organisms are unable to pass through the membrane, sealing said receptacle, and contacting an external surface of the semi-permeable membrane with a solution containing nutrients or other secondary substances for treatment of the culture whereby such nutrients or secondary substances may pass into the culture solution without contaminants of higher molecular weight being introduced thereto, and whereby said semi-permeable membrane provides the only means for introducing nutrients or secondary substances into the culture.

10. An in-line connector as claimed in claim 8 further characterized in that the membrane is selected to restrict the rate of flow of the secondary substance whereby the rate of transfer of the secondary substance to the transfusing liquid is controlled.

9. An in-line connector for use with drip-sets, the connector comprising a first port for connection to a source of sterile liquid, a second port for connection to a transfer tube or injection module and a third port through which secondary substances may be introduced, said first and second ports being connected to said third port by way of a semi-permeable membrane whereby drugs and/or nutritional solutes may be introduced to the solution in a transfusing liquid without introducing external contaminants.

11. An in-line connector as claimed in claim 9 further characterized in that a second semi-permeable membrane spatially separated from the first said membrane is provided whereby the rate of flow of the secondary substance is restricted whereby the rate of transfer of the secondary substance to the transfusing liquid is controlled.

12. An in-line connector as claimed in claim 9 characterized in that the first and second ports are connected to a first chamber and the third port is connected to a second chamber, the first and second chambers being connected by the semi permeable membrane.

13. An in-line connector as claimed in claim 12 further characterized in that at least the first chamber is of translucent material whereby the rate of flow of the transfusing liquid is visible.

14. A method of disinfecting objects comprising inserting the object in a sealable package at least partially formed of semi-permeable membrane material, enclosing a disinfectant solute within the package, sealing the package and contacting the semi-permeable membrane with a solution whereby the solution enters the package to effect disinfection while contaminants of higher molecular weight than the cut-off point of the membrane material are excluded.

15. An injection device for insertion into a patient comprising injection means for subcutaneous insertion, means for temporarily attaching the injection device to a patient and a chamber into which drugs or other injectable solutions may be inserted characterized in that the injection means is connected to the chamber by way of a semi-permeable membrane to prevent contaminated body fluids from leaking back to the chamber.