Pharmaceutical Aspects of Glass and Rubber

Abstract

GLASSFOR many years pharmacists have been "glass conscious" and aware of the necessity of controlling its quality and characteristics when glass containers are used for pharmaceutical preparations. Thus the B.P. 1898 specifies lead-free bottles for solutions of ammonium acetate and citrate and green glass for solution of potassium hydroxide, and in our records are such cases as the extraction of arsenic by potassium carbonate from its glass container and the blackening of suspended bismuth salts by specks of sulphide on the surface of the glass. In recent years, however, we have found it necessary to take an even greater interest in glass because of the gradual introduction of drugs of very high potency, and consequently of small dosage, where regard must be paid to stability, because a small change in structure during a sterilisation process or during storage may mean a considerable drop in potency. Many of these new drugs are sensitive to change of pH and glass can so easily supply the means for this. This more critical attitude was reflected in the B.P. 1932 which, having introduced the modern types of parenteral injections, included control tests for the limit of soluble alkali in the glass containers used and specified those medicaments and preparations which should be packed in provedglass containers. The official tests for the alkalinity of glass were interesting and have led to considerable controversy for there were two schools of thought. Two tests were devised: (a) the crushed glass (or interior) test and (b) the surface test. The crushed glass test was final, for any glass passing that test must also pass the surface test, but not necessarily vice versa. On the other hand it was urged that the surface test was a "practical" test because only the surface came into contact with the medicament. The tests were restricted to containers with capacities of 0-5 ml. to 25 ml. It did not appear logical to apply both tests for only the relatively expensive borosilicate glass would pass both tests whilst the cheaper soft soda-lime glass would rarely pass even the surface test. It is inevitable, of course, that economics should be important and the problem of control of the quality of glass will probably vary in different countries according to the availability of the raw materials. Thus, in Britain borosilicate glass is not in good supply. The problem, however, began to resolve itself by the introduction of the so-called "surfacetreated" soda-lime glass whereby it is possible to produce on its surface a resistant skin of silica which will pass a surface test but not necessarily the "crushed glass'' test. The glass tech'nologists urged the adoption of this surface treated glass for containers, other than ampoules, when an alkali limit was essential. The B.P. 1953 has, in effect, done so; the "crushed" test has been deleted and a surface test retained, but without limitation to the capacity of vessels. 1 feel, however, that this surfacetreated glass has been officially taken on trust for there are no published 1008

A pre‐processing technique to decrease inspection time in glass tube production lines

“…longitudinal size = tube speed × line acquisition period (2) orthogonal frame size = orthogonal size…”

“…Glass tubes, to be used as containers for pharmaceutical use such as vials, syringes, and carpules, are typically been made of borosilicate glass, which is widely considered the most traditional and effective choice for parenteral drug containers or delivery systems [1,2]. Such kind of glass can present production defects like knot inclusions (blobs), lines of air, or flexible fragments called lamellae, and these defects can produce subsequent problems and pharmaceutical recalls [1,3,4].…”

Row‐level algorithm to improve real‐time performance of glass tube defect detection in the production phase

“…The main types of defects that can occur in the production of pharmaceutical glass tubes [1, 8], relevant for their critical dimensions and for the significant impact they can have on the final quality of the product are (i) Knot inclusion (blobs), due to imperfections in the raw materials used in the furnace appears on the captured image as dark patches (Fig. 2).…”

“…Glass tubes that must be later converted into pharmaceutical containers such as vials, syringes, and carpules have historically been made of borosilicate glass [1, 2]. This kind of glass can present defects such as knot inclusions (blobs) due to imperfections in the raw materials used in the furnace, lines of air, or flexible fragments called lamellae and these defects can cause subsequent problems and pharmaceutical recalls [2–6].…”

Structural identification of extractables from rubber closures used for pre-filled semisolid drug applicator by chromatography, mass spectrometry, and organic synthesis

“…It was known that extractables or leachables from rubber closures into drug products can be detrimental since many of the materials extracted from closures are active chemicals which could be toxic, pyrogenic or even affect the stability of the active ingredients or interfere with the assays [1][2][3][4][5][6]. Regulatory authorities have increased their scrutiny of drug delivery products or medical devices which come into direct or indirect contact with rubber/plastic materials, inks, and adhesives.…”