# US 2016/0355429 A1 · Fused quartz tubing for pharmaceutical packaging

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- Number: US 2016/0355429 A1
- Document ID: US20160355429A1
- Status: Published application
- Kind: A1
- Application number: 15/176,259
- Filed: 2016-06-08
- Published: 2016-12-08
- Earliest claimed: 2006-06-20
- Assignees: Momentive Performance Materials Inc.
- Applicants: Momentive Performance Materials Inc.
- Inventors: Kipyung Ahn; Guangjun Xu; Martin Panchula; Samuel Conzone; Tianjun Rong; Konstantin S. Zuyev; Yen Zhou
- Web page: https://patentgrep.com/patent/US20160355429A1

## CPC

- C03C 3/06: with more than 90% silica by weight, e.g. quartz {(C03C3/045 takes precedence)}
- A61J 1/00: Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00)
- A61J 1/1468: {Containers characterised by specific material properties}
- B65D 1/00: Rigid or semi-rigid containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material or by deep-drawing operations performed on sheet material (with curved or partially-curved cross-section made by winding or bending paper B65D3/00; with polygonal cross-section formed by folding B65D5/00; specially constructed to be opened by cutting, piercing or tearing of wall portions B65D17/00; rigid pallets with side walls B65D19/02)
- C03B 1/00: Preparing the batches (chemical compositions C03C)
- C03C 4/00: Compositions for glass with special properties
- C03C 4/085: {for ultraviolet absorbing glass}
- C03C 4/20: for chemical resistant glass
- C03B 17/04: Forming tubes or rods by drawing from stationary or rotating tools or from forming nozzles
- C03C 2201/11: containing chlorine
- C03C 2201/23: containing hydroxyl groups
- C03C 2201/32: containing aluminium (C03C2201/36 takes precedence)
- C03C 2201/3423: Cerium
- C03C 2201/42: containing titanium
- C03C 2203/10: Melting processes
- C03C 2204/00: Glasses, glazes or enamels with special properties
- Y10T 428/131: Glass, ceramic, or sintered, fused, fired, or calcined metal oxide or metal carbide containing [e.g., porcelain, brick, cement, etc.]
- C03C: CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- C03B: MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A high silica glass composition comprising about 92 to about 99.9999 wt. % SiO2 and from about 0.0001 to about 8 wt. % of at least one dopant selected from Al2O3, CeO2, TiO2, La2O3, Y2O3, Nd2O3, other rare earth oxides, and mixtures of two or more thereof. The glass composition has a working point temperature ranging from 600 to 2,000° C. These compositions exhibit stability similar to pure fused quartz, but have a moderate working temperature to enable cost effective fabrication of pharmaceutical packages. The glass is particularly useful as a packaging material for pharmaceutical applications, such as, for example pre-filled syringes, ampoules and vials.

## Claims

### Claim 1

A silica glass composition comprising about 92 to about 99.9 wt. % SiO2 and about 0.1 to about 8 wt. % of a dopant selected from Al2O3, GeO2, Ga2O3, CeO2, ZrO2, TiO2, Y2O3, a rare earth oxide, or mixtures of two or more thereof, wherein the composition does not contain an appreciable amount of alkali metals, alkaline earth metals, or borate ions.

### Claim 2 (depends on 1)

The glass composition of claim 1, wherein a fused glass article formed from the composition has a total extractable metal concentration of about 8 mg/L or less when subjected to HCl digestion, the total extractable metal concentration being represented by the total concentration of Al, B, Na, Ca, K, Li, Ba, and Mg extracted upon HCl digestion.

### Claim 3 (depends on 1)

The glass composition of claim 1 comprising about 96 to about 99.9 wt % SiO2.

### Claim 4 (depends on 2)

The glass composition of claim 2, wherein the total extractable metal concentration is about 5 mg/L or less.

### Claim 5 (depends on 2)

The glass composition of claim 2, wherein the total extractable metal concentration is about 1 mg/L or less.

### Claim 6 (depends on 1)

The glass composition of claim 1, wherein the glass composition exhibits a working point temperature in the range of from about 1,000 to about 2,000° C.

### Claim 7 (depends on 1)

The glass composition of claim 1, wherein the glass composition exhibits a softening point temperature in the range of about 500 to about 1,700° C.

### Claim 8 (depends on 1)

The glass composition of claim 1, wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics when subjected to HCl digestion: Na (<7.0 mg/L), Ca (<1.0 mg/L), B (<2.5 mg/L), Al (<1.25 mg/L), K (<0.03 mg/L), or Mg (<0.01 mg/L).

### Claim 9 (depends on 1)

The glass composition of claim 1, wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics when subjected to HCl digestion: Na (<7.0 mg/L), Ca (<1.0 mg/L), B (<2.5 mg/L), Al (<1.25 mg/L), K (<0.03 mg/L), and Mg (<0.01 mg/L).

### Claim 10 (depends on 1)

The glass composition of claim 1, wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics when subjected to HCl digestion: Na (<0.1 mg/L), Ca (<0.05 mg/L), B (<0.01 mg/L), Al (<0.05 mg/L), Mg (<0.01 mg/L), or K (<0.01 mg/L).

### Claim 11 (depends on 1)

The glass composition of claim 1, wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics when subjected to HCl digestion: Na (<0.1 mg/L), Ca (<0.05 mg/L), B (<0.01 mg/L), Al (<0.05 mg/L), Mg (<0.01 mg/L), and K (<0.01 mg/L).

### Claim 12 (depends on 1)

The glass composition of claim 1, wherein the total concentration of metal impurities is about 1.0 wt. % or less.

### Claim 13 (depends on 1)

The glass composition of claim 1, wherein the total concentration of metal impurities is about 0.5 wt. % or less.

### Claim 14 (depends on 1)

The glass composition of claim 1, wherein the total concentration of metal impurities is about 0.015 wt. % or less.

### Claim 15 (depends on 1)

The glass composition of claim 1, further comprising a UV blocker comprising Ti, Ce, Fe, or combinations of two or more thereof, the UV blocker being present in amount of from about 0.001 to about 0.5 wt %.

### Claim 16 (depends on 1)

The glass composition of claim 1, wherein a fused glass article formed from the glass composition has an OH concentration of 0.5% or less, a Cl concentration of 0.5% or less, or an OH concentration and Cl concentration of 0.5% or less.

### Claim 17 (depends on 1)

The glass composition of claim 1, wherein a fused glass article formed from the glass composition has an OH concentration of 150 ppm or less, a Cl concentration 150 ppm or less, or an OH concentration and Cl concentration of 150 ppm or less.

### Claim 18 (depends on 1)

The glass composition of claim 1, wherein a fused glass article formed from the glass composition has an OH concentration of 50 ppm or less, a Cl concentration of 50 ppm or less, or an OH concentration and Cl concentration of 50 ppm or less.

### Claim 19 (depends on 1)

The glass composition of claim 1, wherein a fused glass article formed from the glass composition has an OH concentration of 10 ppm or less, a Cl concentration of 10 ppm or less, or an OH concentration and Cl concentration of 10 ppm or less.

### Claim 20 (depends on 1)

The glass composition of claim 1, wherein the glass composition exhibits a coefficient of thermal expansion of less than 3 ppm/K.

### Claim 21 (depends on 1)

The glass composition of claim 1, wherein the glass composition exhibits a coefficient of thermal expansion less than 2 ppm/K.

### Claim 22 (depends on 1)

The glass composition of claim 1, wherein the glass composition exhibits a coefficient of thermal expansion of less than 1 ppm/K.

### Claim 23 (depends on 1)

The glass composition of claim 1, having a working point temperature of about 1,700° C. or less.

### Claim 24

A glass article comprising a silica glass composition comprising about 92 to about 99.9 wt. % SiO2 and about 0.1 to about 8 wt. % of a dopant selected from Al2O3, GeO2, Ga2O3, CeO2, ZrO2, TiO2, Y2O3, a rare earth oxide, or mixtures of two or more thereof, wherein the silica glass composition does not contain an appreciable amount of alkali metals, alkaline earth metals, or borate ions, the article having a total extractable metal concentration of about 8 mg/L or less when subjected to HCl digestion, the total extractable metal concentration being represented by the total concentration of Al, B, Na, Ca, K, Li, Ba, and Mg extracted upon HCl digestion; wherein the glass article is formed by a continuous draw process.

### Claim 25

A silica glass composition comprising at least 99.9% wt. % SiO2 and a dopant selected from Al2O3, GeO2, Ga2O3, CeO2, ZrO2, TiO2, Y2O3, a rare earth oxide, or mixtures of two or more thereof in an amount of about 0.1 to about 0.0001 wt. %, wherein the composition does not contain an appreciable amount of alkali metals, alkaline earth metals, or borate ions.

### Claim 26 (depends on 25)

The glass composition of claim 25 comprising greater than about 99.95 wt. % SiO2.