WO2009076603A1 - Depyrogenating plastic containers - Google Patents

Depyrogenating plastic containers Download PDF

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Publication number
WO2009076603A1
WO2009076603A1 PCT/US2008/086598 US2008086598W WO2009076603A1 WO 2009076603 A1 WO2009076603 A1 WO 2009076603A1 US 2008086598 W US2008086598 W US 2008086598W WO 2009076603 A1 WO2009076603 A1 WO 2009076603A1
Authority
WO
WIPO (PCT)
Prior art keywords
minutes
containers
deionized water
rinsing
consisting essentially
Prior art date
Application number
PCT/US2008/086598
Other languages
French (fr)
Inventor
Tasadduq Hussain
Todd William Meyer
Original Assignee
Rexam Healthcare Packaging Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rexam Healthcare Packaging Inc. filed Critical Rexam Healthcare Packaging Inc.
Publication of WO2009076603A1 publication Critical patent/WO2009076603A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat

Definitions

  • the present disclosure relates to a process for depyrogenating plastic containers such as plastic vials by physically dislodging and removing pyrogens from the containers.
  • Glass containers including glass vials used for medical applications for example, currently are depyrogenated by burning off the pyrogens using ovens, employing water at 100°C or more, and/or using surfactants or acids or the like.
  • depyrogenation of containers must involve baking or boiling of the containers, and/or use of cleansing agents and not just water.
  • 2007/0026173 Al discloses plastic containers, including plastic vials, that are well suited for use in medical applications in place of Type I glass currently employed.
  • a general object of the present disclosure is to provide a process for depyrogenating plastic containers, including plastic vials, with water under 100°C and without cleansing agents.
  • the present disclosure embodies a number of aspects that can be implemented separately from or in combination with each other.
  • a cleansing-agent-free process for depyrogenating plastic containers includes washing the containers with liquid consisting essentially of tap water at about 70°C to about 80°C for about 2 minutes to about 8 minutes, rinsing the containers with liquid consisting essentially of deionized water at about
  • cleaning agents means chemicals selected from the group consisting of detergents, soaps, other surfactants, salts, acids, oxidants, and oxygenated liquids, and excluding tap water and deionized water.
  • cleaning agents means chemicals selected from the group consisting of detergents, soaps, other surfactants, salts, acids, oxidants, and oxygenated liquids, and excluding tap water and deionized water.
  • the term “about” means within +/- 15%.
  • An exemplary but presently preferred process of depyrogenating plastic containers free of cleansing agents and with liquid consisting essentially of tap water and deionized water in accordance with the present disclosure involves the following steps, which may be carried out sequentially.
  • a particularly preferred time for this step is about 2 minutes.
  • the particularly preferred temperature range for one or more of the preceding rinsing steps may be about 20 0 C to about 21 0 C. 6) Rinse with deionized water at about 6O 0 C to about 8O 0 C for about 1 minute to about 2 minutes.
  • the particularly preferred temperature may be about 70 0 C.
  • a particularly preferred time for this step is about 1 minute.
  • the process is carried out absent or free of cleansing agents and may take about 10 to about 14 minutes total to complete and, preferably, takes about 12 minutes total to complete.
  • the preceding steps may be carried out by programming different cycles (pre- wash, wash, and rinse) in a washing machine to provide the disclosed temperatures, times, and sequencing. Between each different type of cycle (pre-wash, wash, and rinse), and preferably between each individual cycle, the specified water is replaced with the specified water of the subsequent step. For example, the water may be drained and replenished with a fresh volume of the specified water at the specified temperatures.
  • the number of pre-wash, wash, and rinse cycles, time durations and temperatures can be adjusted within the novel and nonobvious critical limits disclosed herein for specific container designs and specific bioburden loads.
  • a washing/rinsing machine preferably would be equipped with appropriately designed and positioned spray nozzles to suit the particular container shape.
  • Water pressure, temperature and flow volume also preferably would be easily adjustable.
  • the machine design should allow application of effective water pressure, flow volume and temperature at various container placement locations in the machine.
  • a Lancer Glass Washer model 1600UP is currently preferred for laboratory use.
  • a Perm Machinery Corp model RW-800 can be used for production scale requirements.

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Detergent Compositions (AREA)

Abstract

A cleansing-agent-free process for depyrogenating plastic containers with liquid consisting essentially of tap water and deionized water. The process includes washing the containers with tap water at about 70°C to about 80°C for about 2 minutes to about 8 minutes, rinsing the containers with deionized water at about 15°C to 25°C for about 1 minute to about 10 minutes, and rinsing the containers with deionized water at about 6O°C to about 8O°C for about 1 minute to about 2 minutes.

Description

DEPYROGENATING PLASTIC CONTAINERS
The present disclosure relates to a process for depyrogenating plastic containers such as plastic vials by physically dislodging and removing pyrogens from the containers.
Glass containers, including glass vials used for medical applications for example, currently are depyrogenated by burning off the pyrogens using ovens, employing water at 100°C or more, and/or using surfactants or acids or the like. In other words, the well-settled conventional wisdom in the art is that depyrogenation of containers must involve baking or boiling of the containers, and/or use of cleansing agents and not just water. US patent document
2007/0026173 Al discloses plastic containers, including plastic vials, that are well suited for use in medical applications in place of Type I glass currently employed. A general object of the present disclosure is to provide a process for depyrogenating plastic containers, including plastic vials, with water under 100°C and without cleansing agents.
The present disclosure embodies a number of aspects that can be implemented separately from or in combination with each other.
A cleansing-agent-free process for depyrogenating plastic containers, in accordance with one aspect of the present disclosure, includes washing the containers with liquid consisting essentially of tap water at about 70°C to about 80°C for about 2 minutes to about 8 minutes, rinsing the containers with liquid consisting essentially of deionized water at about
150C to 250C for about 1 minute to about 10 minutes, and rinsing the containers with liquid consisting essentially of deionized water at about 5O0C to about 7O0C to about 80°C for about 1 minute to about 2 minutes. These parameters can be adjusted within the aforementioned limits depending on the size and shape of the containers and vials, the amount of bioburden/endotoxins on the containers and the design of the washing system. For purposes of the present disclosure, the terminology "tap water" means potable tap water. Also, the expression "deionized water" in the present disclosure means U.S. Pharmacopeia (USP) grade deionized water or better. Further, the terminology "cleansing agents" means chemicals selected from the group consisting of detergents, soaps, other surfactants, salts, acids, oxidants, and oxygenated liquids, and excluding tap water and deionized water. As used herein, the term "about" means within +/- 15%.
An exemplary but presently preferred process of depyrogenating plastic containers free of cleansing agents and with liquid consisting essentially of tap water and deionized water in accordance with the present disclosure involves the following steps, which may be carried out sequentially.
1) Prewash with tap water at about 70°C to about 8O0C for about 2 minutes to about 4 minutes. A particularly preferred time for this step is about 2 minutes.
2) Wash with tap water at about 70°C to about 8O0C for about 2 minutes to about 4 minutes. A particularly preferred time for this step is about 4 minutes. 3) Rinse with deionized water at 150C to 250C for about 1 minute to about 2 minutes. A particularly preferred time for this step is about 1 minute.
4) Rinse with deionized water at 150C to 25°C for about 2 minutes to about 4 minutes. A particularly preferred time for this step is about 2 minutes.
5) Rinse with deionized water at 15°C to 250C for about 2 minutes to about 4 minutes. A particularly preferred time for this step is about 2 minutes.
The particularly preferred temperature range for one or more of the preceding rinsing steps may be about 200C to about 210C. 6) Rinse with deionized water at about 6O0C to about 8O0C for about 1 minute to about 2 minutes. The particularly preferred temperature may be about 700C. A particularly preferred time for this step is about 1 minute.
The process is carried out absent or free of cleansing agents and may take about 10 to about 14 minutes total to complete and, preferably, takes about 12 minutes total to complete.
The preceding steps may be carried out by programming different cycles (pre- wash, wash, and rinse) in a washing machine to provide the disclosed temperatures, times, and sequencing. Between each different type of cycle (pre-wash, wash, and rinse), and preferably between each individual cycle, the specified water is replaced with the specified water of the subsequent step. For example, the water may be drained and replenished with a fresh volume of the specified water at the specified temperatures. The number of pre-wash, wash, and rinse cycles, time durations and temperatures can be adjusted within the novel and nonobvious critical limits disclosed herein for specific container designs and specific bioburden loads. A washing/rinsing machine preferably would be equipped with appropriately designed and positioned spray nozzles to suit the particular container shape. Water pressure, temperature and flow volume also preferably would be easily adjustable. The machine design should allow application of effective water pressure, flow volume and temperature at various container placement locations in the machine. A Lancer Glass Washer model 1600UP is currently preferred for laboratory use. A Perm Machinery Corp model RW-800 can be used for production scale requirements.
Given the conventional wisdom in the art, satisfactory depyrogenation was not expected from a process using tap water and deionized water without boiling temperatures and/or cleansing agents. However, the disclosed process did indeed result in successful depyrogenation of equal to or greater than a 3 log reduction in endotoxins from a pre-process state to a post- process state and without cleansing agents and at water temperatures of less than 100°C.
There thus has been disclosed a method of depyrogenating plastic containers that fully satisfies the objects and aims previously set forth. The disclosure has been presented in conjunction with an exemplary embodiment, and modifications and variations have been discussed. Other modifications and variations readily will suggest themselves to persons of ordinary skill in the art in view of the foregoing discussion. The disclosure is intended to embrace all such modifications and variations as fall within the spirit and broad scope of the appended claims.

Claims

Claims
1.
A cleansing-agent-free process for depyrogenating plastic containers, which includes the steps of:
(a) prewashing the containers with liquid consistent essentially of tap water at about 70°C to about 8O0C for about 2 minutes to about 4 minutes,
(b) washing the containers with liquid consisting essentially of tap water at about 700C to about 8O0C for about 2 minutes to about 4 minutes,
(c) rinsing the containers with liquid consisting essentially of deionized water at 150C to 250C for about 1 minute to about 2 minutes,
(d) rinsing the containers with liquid consisting essentially of deionized water at 150C to 250C for about 2 minutes to about 4 minutes,
(e) rinsing the containers with liquid consisting essentially of deionized water at 150C to 250C for about 2 minute to about 4 minutes, and
(f) rinsing the containers with liquid consisting essentially of deionized water at about 6O0C to about 8O0C for about 1 minute to about 2 minutes.
2.
The process set forth in claim 1 wherein said step (a) includes prewashing with tap water at about 700C to about 800C for about 2 minutes.
3.
The process set forth in claim 1 wherein said step (b) includes washing with tap water at about 700C to about 8O0C for about 4 minutes.
4.
The process set forth in claim 1 wherein said step (c) includes rinsing with deionized water at about 150C to about 250C for about 1 minute.
5.
The process set forth in claim 4 wherein said step (c) includes rinsing with deionized water at about 2O0C to about 210C for about 2 minutes to about 4 minutes.
6.
The process set forth in claim 1 wherein said step (d) includes rinsing with deionized water at about 150C to about 250C for about 2 minutes.
7.
The process set forth in claim 6 wherein said step (d) includes rinsing with deionized water at about 2O0C to about 210C for about 2 minutes to about 4 minutes.
8.
The process set forth in claim 1 wherein said step (e) includes rinsing with deionized water at about 150C to about 250C for about 2 minutes.
9.
The process set forth in claim 8 wherein said step (e) includes rinsing with deionized water at about 2O0C to about 210C for about 2 minutes to about 4 minutes.
10.
The process set forth in claim 1 wherein said step (f) includes rinsing the containers with liquid consisting essentially of deionized water at about 6O0C to about 8O0C for about 1 minute.
11.
The process set forth in claim 10 wherein said step (f) includes rinsing the containers with liquid consisting essentially of deionized water at about 7O0C for about 1 minute to about 2 minutes.
12.
The process set forth in claim 1 wherein said step (a) includes prewashing with tap water at about 70°C to about 800C for about 2 minutes, said step (b) includes washing with tap water at about 700C to about 800C for about 4 minutes, said step (c) includes rinsing with deionized water at about 2O0C to about 210C for about 1 minute, said step (d) includes rinsing with deionized water at about 2O0C to about 210C for about 2 minutes, said step (e) includes rinsing with deionized water at about 2O0C to about 210C for about 2 minutes, and said step (f) includes rinsing the containers with liquid consisting essentially of deionized water at about 7O0C for about 1 minute.
13.
The process set forth in claim 1 wherein the process is carried out using the tap water and the deionized water as the only liquids.
14.
The process set forth in claim 1 wherein between said steps (a) through (f) the water is replaced with a fresh volume of the water of a subsequent step.
15.
A cleansing-agent-free plastic container depyrogenated by the process set forth in claim 1.
16. A process for depyrogenating plastic containers, which includes the steps of:
(a) prewashing the containers with liquid consistent essentially of tap water at about 70°C to about 80°C for about 2 minutes to about 4 minutes,
(b) washing the containers with liquid consisting essentially of tap water at about 70°C to about 8O0C for about 2 minutes to about 4 minutes,
(c) rinsing the containers with liquid consisting essentially of deionized water at 150C to 25°C for about 1 minute to about 2 minutes,
(d) rinsing the containers with liquid consisting essentially of deionized water at 150C to 25°C for about 2 minutes to about 4 minutes,
(e) rinsing the containers with liquid consisting essentially of deionized water at 150C to 25°C for about 2 minute to about 4 minutes, and
(f) rinsing the containers with liquid consisting essentially of deionized water at about 6O0C to about 8O0C for about 1 minute to about 2 minutes, wherein the process is carried out using only the tap water and the deionized water and absent cleansing agents.
17. A process for depyrogenating plastic containers, which includes the steps of:
(a) prewashing the containers with liquid consistent essentially of tap water at about 7O0C to about 80°C for about 2 minutes to about 4 minutes,
(b) washing the containers with liquid consisting essentially of tap water at about 700C to about 8O0C for about 2 minutes to about 4 minutes,
(c) rinsing the containers with liquid consisting essentially of deionized water at 150C to 25°C for about 1 minute to about 2 minutes,
(d) rinsing the containers with liquid consisting essentially of deionized water at 150C to 250C for about 2 minutes to about 4 minutes,
(e) rinsing the containers with liquid consisting essentially of deionized water at 15°C to 25°C for about 2 minute to about 4 minutes, and
(f) rinsing the containers with liquid consisting essentially of deionized water at about 6O0C to about 8O0C for about 1 minute to about 2 minutes, wherein the process is carried out absent chemicals selected from the group consisting of detergents, soaps, other surfactants, salts, acids, oxidants, and oxygenated liquids.
18.
A cleansing-agent-free process for depyrogenating plastic containers, which includes the steps of:
(a) washing the containers with liquid consisting essentially of tap water at about 70°C to about 8O0C for about 2 minutes to about 8 minutes,
(b) rinsing the containers with liquid consisting essentially of deionized water at 150C to 250C for about 1 minute to about 10 minutes, and
(c) rinsing the containers with liquid consisting essentially of deionized water at about 6O0C to about 8O0C for about 1 minute to about 2 minutes.
PCT/US2008/086598 2007-12-13 2008-12-12 Depyrogenating plastic containers WO2009076603A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US182707A 2007-12-13 2007-12-13
US12/001,827 2007-12-13

Publications (1)

Publication Number Publication Date
WO2009076603A1 true WO2009076603A1 (en) 2009-06-18

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PCT/US2008/086598 WO2009076603A1 (en) 2007-12-13 2008-12-12 Depyrogenating plastic containers

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WO (1) WO2009076603A1 (en)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5508189A (en) * 1994-04-26 1996-04-16 Pepperdine University Regeneration of plants from cultured guard cell protoplasts
EP1384670A1 (en) * 2001-05-01 2004-01-28 Toyo Seikan Kaisya, Ltd. Method and system for sterilizing food packaging container or food filling system
WO2004043499A2 (en) * 2002-11-12 2004-05-27 Minntech Corporation Apparatus and method for steam reprocessing flexible endoscopes
US20050119230A1 (en) * 2003-09-18 2005-06-02 Alexandra Glausch Pharmaceutical products comprising bisphosphonated
WO2007007453A1 (en) * 2005-07-07 2007-01-18 Toyo Seikan Kaisha, Ltd. Process and apparatus for producing beverage filled into container

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5508189A (en) * 1994-04-26 1996-04-16 Pepperdine University Regeneration of plants from cultured guard cell protoplasts
EP1384670A1 (en) * 2001-05-01 2004-01-28 Toyo Seikan Kaisya, Ltd. Method and system for sterilizing food packaging container or food filling system
WO2004043499A2 (en) * 2002-11-12 2004-05-27 Minntech Corporation Apparatus and method for steam reprocessing flexible endoscopes
US20050119230A1 (en) * 2003-09-18 2005-06-02 Alexandra Glausch Pharmaceutical products comprising bisphosphonated
WO2007007453A1 (en) * 2005-07-07 2007-01-18 Toyo Seikan Kaisha, Ltd. Process and apparatus for producing beverage filled into container

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