Process and system for producing sterile water and sterile aqueous solutions

A process for producing water substantially free of pyrogens and microorganisms to produce sterile USP XX grade sterile water for injection which comprises passing drinking quality water through a water purification system comprising:

• (a) a filtration step to remove organic impurities;
• (b) a reverse osmosis separation step to remove dissolved solids or ions, pyrogens and microorganisms from said water;
• (c) a deionization step to remove ions from said water and to increase the resistance of said water;
• (d) an ultrafiltration step subsequent to steps (a), (b) and (c) thereby to remove pyrogens from said water;
• (e) a membrane filter step capable of retaining microorganisms;
• and
• (f) periodically washing ion exchange means in the deionization step for removing ions from said water and a membrane utilized in the ultrafiltration step with water heated to a temperature to sterilize microorganisms in said deionization and ultrafiltration steps and to remove impurities accumulated in said deionization step and said ultrafiltration step while avoiding washing steps (a) and (b) with said heated water.

A process for preparing a sterile package containing a sterile dilute aqueous solution formed from sterile USP XX grade water for injection water and irrigation and adapted to be administered to a patient which comprises passing drinking grade water through a water purification system comprising:

• (a) a filtration step to remove organic impurities;
• (b) a reverse osmosis separation step to remove dissolved solids or ions, pyrogens and microorganisms from said water;
• (c) a deionization step to remove ions from said water and to increase the resistance of said water;
• (d) an ultrafiltration step subsequent to steps (a), (b) and (c) thereby to remove pyrogens from said water and produce USP XX grade water for injection or irrigation;
• (e) mixing said sterile water with a sterilized liquid concentrate composition thereby to produce said sterile dilute solution;
• (f) passing said dilute solution through a filter adapted to retain microorganisms into a sterile container;
• and
• (g) periodically washing ion exchange means in the deionization step for removing ions from said water and a membrane utilized in the ultrafiltration step with water heated to a temperature to sterilize microorganisms in said deionization and ultrafiltration steps and to remove impurities accumulated in the deionization and ultrafiltration steps while avoiding steps (a) and (b) with said heated water.

A system for producing USP XX grade sterile water for injection from drinking water which comprises

• (a) a filtration means adapted to remove organic impurities from water;
• (b) a reverse osmosis separation means adapted to remove dissolved solids, microorganisms and pyrogens from water;
• (c) deionization means adapted to remove dissolved solids from water;
• (d) ultrafiltration means downstream of steps (a), (b) and (c) adapted to remove pyrogens and microorganisms from water;
• (e) means for passing the drinking grade water through said first filtration means, said reverse osmosis separation means, said deionization means and said ultrafiltration means;
• (f) means for passing heated water periodically through said deionization means and said ultrafiltration means thereby to remove accumulated pyrogens and microorganisms from said system while avoiding washing means (a) and (b) with said heated water;
• and
• (g) means for passing pressurized water across membranes in said reverse osmosis means to remove accumulated microorganisms from said system.

A system for preparing a package containing a sterile dilute aqueous solution adapted to be administered to a patient said solution being formed from USP XX grade water for injection or irrigation which comprises

• (a) a filtration means adapted to remove organic impurities from water;
• (b) a reverse osmosis separation means adapted to remove dissolved solids, microorganisms and pyrogens from water;
• (c) deionization means adapted to remove dissolved solids from water;
• (d) ultrafiltration means downstream of steps (a), (b) and (c) adapted to remove pyrogens and microorganisms from water;
• (e) means for passing the drinking grade water through said first filtration means, said reverse osmosis separation means, said deionization means and said ultrafiltration means;
• (f) means for passing heated water periodically through said deionization means and said ultrafiltration means thereby to remove accumulated pyrogens and microorganisms from said system while avoiding washing means (a) and (b) with said heated water;
• and
• (g) means for passing pressurized water across membranes in said reverse osmosis means to remove accumulated microorganisms from said system.

A process for producing water substantially free of pyrogens to produce USP XX grade water for injection or irrigation solutions which comprises passing drinking quality water through a water purification system comprising:

• (a) a filtration step to remove organic impurities;
• (b) a reverse osmosis separation step to remove dissolved solids or ions, pyrogens and microorganisms from said water;
• (c) a deionization step to remove ions from said water and to increase the electrical resistance of said water;
• (d) an ultrafiltration step downstream of steps (a), (b) and (c) thereby to remove pyrogens from said water;
• and
• (e) periodically washing a membrane utilized in the ultrafiltration step with water heated to a temperature to sterilize microorganisms in said systems and to remove impurities accumulated on said membrane while avoiding washing steps (a) and (b) with said heated water.

A process for producing water substantially free of pyrogens and microorganisms to produce sterile USP XX grade sterile water for injection which comprises passing drinking quality water through a water purification system comprising:

• (a) a filtration step to remove organic impurities;
• (b) a reverse osmosis separation step to remove dissolved solids or ions, pyrogens and microorganisms from said water;
• (c) a deionization step to remove ions from said water and to increase the resistance of said water;
• (d) an ultrafiltration step subsequent to steps (a), (b) and (c) thereby to remove pyrogens from said water;
• (e) a membrane filter step capable of retaining microorganisms;
• and
• (f) periodically washing a membrane utilized in the ultrafiltration step with water heated to a temperature to sterilize microorganisms in said systems and to remove impurities accumulated on said membrane while avoiding washing steps (a) and (b) with said heated water.

A process for preparing a sterile package containing a sterile dilute aqueous solution formed from sterile USP XX grade water for injection water and irrigation and adapted to be administered to a patient which comprises passing drinking grade water through a water purification system comprising:

• (a) a filtration step to remove organic impurities;
• (b) a reverse osmosis separation step to remove dissolved solids or ions, pyrogens and microorganisms from said water;
• (c) a deionization step to remove ions from said water and to increase the resistance of said water;
• (d) an ultrafiltration step subsequent to steps (a), (b) and (c) thereby to remove pyrogens from said water and produce USP XX grade water for injection or irrigation;
• (e) mixing said sterile water with a sterilized liquid concentrate composition thereby to produce said sterile dilute solution;
• (f) passing said dilute solution through a filter adapted to retain microorganisms into a sterile container;
• and
• (g) periodically washing ion exchange means in the ultrafiltration step with water heated to a temperature to sterilize microorganisms in said system and to remove impurities accumulated on said membrane while avoiding steps (a) and (b) with said heated water.