Manufacturing industry medical products made of glass and polymeric materials. Tare and packaging of
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Many Pharmacopeial articles are of such nature as to require the greatest attention to the containers in which they are stored or maintained even for short periods of time. While the needs vary widely and some of them are not fully met by the containers available, objective standards are essential. It is the purpose of this chapter to provide such standards as have been developed for the materials of which pharmaceutical containers principally are made, i.
A clear and colorless or a translucent container that is made light-resistant by means of an opaque enclosure see General Notices is exempt from the requirements for Light Transmission. Where dry oral dosage forms, not meant for constitution into solution, are intended to be packaged in a container defined in the section Polyethylene Containers , the requirements given in that section are to be met. Guidelines and requirements under Repacking into Single-Unit Containers and Unit-Dose Containers for Nonsterile Solid and Liquid Dosage Forms apply to official dosage forms that are repackaged into single-unit or unit-dose containers or mnemonic packs for dispensing pursuant to prescription.
For transparent glass or plastic pharmaceutical containers, use a spectrophotometer of suitable sensitivity and accuracy for measuring and recording the amount of light transmitted. For translucent glass or plastic pharmaceutical containers, use a spectrophotometer as described above that, in addition, is capable of measuring and recording light transmitted in diffused as well as parallel rays.
Select sections to represent the average wall thickness in the case of blown glass containers, and trim them as necessary to give segments of a size convenient for mounting in the spectrophotometer. After cutting, wash and dry each specimen, taking care to avoid scratching the surfaces. If the specimen is too small to cover the opening in the specimen holder, mask the uncovered portion of the opening with opaque paper or masking tape, provided that the length of the specimen is greater than that of the slit in the spectrophotometer.
Immediately before mounting in the specimen holder, wipe the specimen with lens tissue. Mount the specimen with the aid of a tacky wax, or by other convenient means, taking care to avoid leaving fingerprints or other marks on the surfaces through which light must pass. Mount in the apparatus as described for Glass. When properly placed, the light beam is normal to the surface of the section and reflection losses are at a minimum. Measure the transmittance of the section with reference to air in the spectral region of interest, continuously with a recording instrument or at intervals of about 20 nm with a manual instrument, in the region of to nm.
Table 1. For containers larger than 50 mL, the limits for 50 mL apply. The following tests are designed to determine the resistance to water attack of new not previously used glass containers. The degree of attack is determined by the amount of alkali released from the glass under the influence of the attacking medium under the conditions specified.
This quantity of alkali is extremely small in the case of the more resistant glasses, thus calling for particular attention to all details of the tests and the use of apparatus of high quality and precision. The tests should be conducted in an area relatively free from fumes and excessive dust. Containers of Type I borosilicate glass are generally used for preparations that are intended for parenteral administration. Type I glass containers, or Type II glass containers where stability data demonstrate their suitability , are used for alkaline parenteral preparations.
Type III soda-lime glass containers usually are not used for parenteral preparations, except where suitable stability test data indicate that Type III glass is satisfactory for the parenteral preparations that are packaged therein.
Containers of Type NP glass are intended for packaging nonparenteral articles, i. Table 2. Glass Types and Test Limits.
Special Mortar and Pestle for Pulverizing Glass 2. There must also be an assurance that this water is not contaminated by copper or its products e. The water may be prepared by passing distilled water through a deionizer cartridge packed with a mixed bed of nuclear-grade resin, then through a cellulose ester membrane having openings not exceeding 0. Flush the discharge lines before water is dispensed into test vessels. When the low conductivity specification can no longer be met, replace the deionizer cartridge.
If necessary, neutralize the solution with 0. Powdered Glass Test. Rinse thoroughly with Purified Water 6 or more containers selected at random, and dry them with a current of clean, dry air. Crush the containers into fragments about 25 mm in size, divide about g of the coarsely crushed glass into three approximately equal portions, and place one of the portions in the special mortar. With the pestle in place, crush the glass further by striking 3 or 4 blows with the hammer.
Nest the sieves, and empty the mortar into the No. Repeat the operation on each of the two remaining portions of glass, emptying the mortar each time into the No. Shake the sieves for a short time, then remove the glass from the Nos. Repeat again this crushing and sieving operation. Empty the receiving pan, reassemble the nest of sieves, and shake by mechanical means for 5 minutes or by hand for an equivalent length of time.
Transfer the portion retained on the No. Spread the specimen on a piece of glazed paper, and pass a magnet through it to remove particles of iron that may be introduced during the crushing. Transfer the specimen to a mL conical flask of resistant glass, and wash it with six mL portions of acetone, swirling each time for about 30 seconds and carefully decanting the acetone.
After washing, the specimen should be free from agglomerations of glass powder, and the surface of the grains should be practically free from adhering fine particles. Dry the flask and contents for 20 minutes at , transfer the grains to a weighing bottle, and cool in a desiccator. Use the test specimen within 48 hours after drying. Add Cap all flasks with borosilicate glass beakers that previously have been treated as described for the flasks and that are of such size that the bottoms of the beakers fit snugly down on the top rims of the containers.
Place the containers in the autoclave, and close it securely, leaving the vent cock open. Heat until steam issues vigorously from the vent cock, and continue heating for 10 minutes. Close the vent cock, and adjust the temperature to , taking 19 to 23 minutes to reach the desired temperature.
Reduce the heat so that the autoclave cools and comes to atmospheric pressure in 38 to 46 minutes, being vented as necessary to prevent the formation of a vacuum. Cool the flask at once in running water, decant the water from the flask into a suitably cleansed vessel, and wash the residual powdered glass with four mL portions of High-Purity Water , adding the decanted washings to the main portion.
Add 5 drops of Methyl Red Solution , and titrate immediately with 0. If the volume of titrating solution is expected to be less than 10 mL, use a microburet. Record the volume of 0. The volume does not exceed that indicated in Table 2 for the type of glass concerned. Water Attack at Rinse thoroughly 3 or more containers, selected at random, twice with High-Purity Water. Place the pooled specimen in a mL conical flask of resistant glass, add 5 drops of Methyl Red Solution , and titrate, while warm, with 0.
Complete the titration within 60 minutes after opening the autoclave. Perform the in vitro biological tests according to the procedures set forth under Biological Reactivity Tests, In Vitro Materials that meet the requirements of the in vitro tests are not required to undergo further testing.
No plastic class designation is assigned to these materials. Materials that do not meet the requirements of the in vitro tests are not suitable for containers for drug products. If a plastic class designation is needed for plastics and other polymers that meet the requirements under Biological Reactivity Tests, In Vitro 87 , perform the appropriate in vivo tests specified for Classification of Plastics under Biological Reactivity Tests, In Vivo The following tests, designed to determine physical and chemical properties of plastics and their extracts, are based on the extraction of the plastic material, and it is essential that the designated amount of the plastic be used.
Also, the specified surface area must be available for extraction at the designated temperature. Transfer the subdivided Sample to a glass-stoppered, mL graduated cylinder of Type I glass, and add about mL of Purified Water.
Agitate for about 30 seconds, drain off and discard the liquid, and repeat with a second washing. Transfer the prepared Sample to a suitable extraction flask, and add the required amount of Extracting Medium.
Extract by heating in a water bath at the temperature specified for the Extracting Medium for 24 hours. Cool, but not below Pipet 20 mL of the extract of the prepared Sample into a suitable container. Use this portion in the test for Buffering Capacity.
Immediately decant the remaining extract into a suitably cleansed container, and seal. Similarly evaporate Adjust with 1 N acetic acid or 6 N ammonium hydroxide to a pH between 3. To each tube add 1. Treat a Plastics for ophthalmics are composed of a mixture of homologous compounds, having a range of molecular weights. Such plastics frequently contain other substances such as residues from the polymerization process, plasticizers, stabilizers, antioxidants, pigments, and lubricants.
Factors such as plastic composition, processing and cleaning procedures, contacting media, inks, adhesives, absorption, adsorption and permeability of preservatives, and conditions of storage may also affect the suitability of a plastic for a specific use.
The standards and tests provided in this section characterize high-density and low-density polyethylene containers that are interchangeably suitable for packaging dry oral dosage forms not meant for constitution into solution.
Where stability studies have been performed to establish the expiration date of a particular dry oral dosage form not meant for constitution into solution in a container meeting the requirements set forth herein for either high- or low-density polyethylene containers, then any other polyethylene container meeting the same sections of these requirements may be similarly used to package such dosage form, provided that the appropriate stability programs are expanded to include the alternative container, in order to assure that the identity, strength, quality, and purity of the dosage form are maintained throughout the expiration period.
Both high- and low-density polyethylene are long-chain polymers synthesized under controlled conditions of heat and pressure, with the aid of catalysts from not less than The other olefin ingredients most frequently used are butene, hexene, and propylene.
The ingredients used to manufacture the polyethylene, and those used in the fabrication of the containers, conform to the requirements in the applicable sections of the Code of Federal Regulations , Title High-density polyethylene and low-density polyethylene both have an IR absorption spectrum that is distinctive for polyethylene, and each possesses characteristic thermal properties.
High-density polyethylene has a density between 0. Low-density polyethylene has a density between 0. The permeation properties of molded polyethylene containers may be altered when re-ground polymer is incorporated, depending upon the proportion of re-ground material in the final product. Other properties that may affect the suitability of polyethylene used in containers for packaging drugs are: oxygen and moisture permeability, modulus of elasticity, melt index, environmental stress crack resistance, and degree of crystallinity after molding.
The requirements in this section are to be met when dry oral dosage forms, not meant for constitution into solution, are intended to be packaged in a container defined by this section. Taking care to avoid scratching the surfaces, wipe the specimens with dry paper or, if necessary, clean them with a soft cloth dampened with methanol, and permit them to dry. Securely mount the specimens on both sides of the KRS-5 internal reflection plate, ensuring adequate surface contact.
Polymers from Renewable Resources
Many Pharmacopeial articles are of such nature as to require the greatest attention to the containers in which they are stored or maintained even for short periods of time. While the needs vary widely and some of them are not fully met by the containers available, objective standards are essential. It is the purpose of this chapter to provide such standards as have been developed for the materials of which pharmaceutical containers principally are made, i. A clear and colorless or a translucent container that is made light-resistant by means of an opaque enclosure see General Notices is exempt from the requirements for Light Transmission. Where dry oral dosage forms, not meant for constitution into solution, are intended to be packaged in a container defined in the section Polyethylene Containers , the requirements given in that section are to be met.
Polyethylene terephthalate sometimes written poly ethylene terephthalate , commonly abbreviated PET , PETE , or the obsolete PETP or PET-P, is the most common thermoplastic polymer resin of the polyester family and is used in fibres for clothing, containers for liquids and foods, thermoforming for manufacturing, and in combination with glass fibre for engineering resins. PET consists of polymerized units of the monomer ethylene terephthalate, with repeating C 10 H 8 O 4 units. Depending on its processing and thermal history, polyethylene terephthalate may exist both as an amorphous transparent and as a semi-crystalline polymer. The monomer bis 2-hydroxyethyl terephthalate can be synthesized by the esterification reaction between terephthalic acid and ethylene glycol with water as a byproduct, or by transesterification reaction between ethylene glycol and dimethyl terephthalate DMT with methanol as a byproduct.
Plastic Recycling Glossary of Terms
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The many facets and avenues within the plastic recycling and reprocessing industry mean that there are variations when it comes to the terminology used. While those that are at the beginning of their plastic recycling solutions may not be familiar with the language used at all. We strive to be transparent in all that we do.
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