What are the inspection items for eye drop bottles

 As an important tool for eye medication, the quality of eye drop bottles is directly related to the user's vision health and safety. According to the standard YBB00062002-2015 "Low-density polyethylene eye drop bottles", the inspection items of eye drop bottles include the following:

eye drop bottles

Appearance and identification: The eye drop bottle must first have an intact appearance without obvious foreign matter or defects. At the same time, the uniqueness and identifiability of the product are ensured through labeling and packaging to avoid confusion.

Density and sealing: The density test of the eye drop bottle ensures that the bottle material meets the requirements, while the sealing test ensures that it does not leak during use to avoid contamination and waste of the liquid medicine.

Drip volume and visible foreign matter: The accurate control of the drip volume directly affects the dosage of the liquid medicine, while the detection of visible foreign matter eliminates any impurities that may affect the clarity and safety of the liquid medicine.

Dissolution test: Including the detection of clarity, pH change, oxidizable substances, heavy metals, absorbance and non-volatile substances to evaluate the stability and safety of the liquid medicine in the bottle.

Ignition residue and n-hexane non-volatile matter: Ensure the compliance of the residue after the bottle is burned under specific conditions, and exclude the possible contamination of the non-volatile matter on the liquid medicine.

Decolorization test and microbial limit: The decolorization test detects the effect of the bottle material on the photostability of the liquid medicine, and the microbial limit ensures the sterility of the bottle before and after use.

Biological test: Biological tests include abnormal toxicity and eye irritation tests. The abnormal toxicity test ensures that the bottle material will not have adverse reactions or toxic effects on the human body; the eye irritation test evaluates the irritation reaction that may be caused by the liquid medicine contacting the eyes.

Through the above series of strict testing items, the manufacturers and users of eye drop bottles can ensure the quality and safety of the products, thereby effectively ensuring the effect of eye drug administration and the health of users. These testing items not only meet the requirements of the standards, but also reflect the high requirements and challenges of pharmaceutical processes and technologies, providing reliable protection for eye health.

Decolorization test of eye drop bottles

 Eye drop bottles are an important packaging form for ophthalmic drugs. Since they are in direct contact with the eyes, their quality and safety are particularly important. The decolorization test is an important test item in their quality standards.

5ml eye dropper bottle

Eye drop bottles are usually made of low-density polyethylene (LDPE) raw materials, which have excellent physical properties and chemical stability. The decolorization experiment is mainly aimed at packaging with colored plastic materials. Its purpose is to detect whether there is a migration risk of colorants and to avoid contamination of drugs due to migration of colorants, which may affect drug treatment effects and even patient health. Therefore, decolorization experimental testing of packaging containing colorants has become the key to ensuring drug safety.

In the YBB00062002-2015 "Low Density Polyethylene Medicinal Eye Drop Bottles" standard, the operations and requirements for the decolorization test are as follows: Take 50 c of the entire part of the product into 2cmx0.3cm small pieces, and place three stoppered cones respectively. In the bottle, add 4% acetic acid solution (60C+2C), 65% ethanol solution (25C+2C), and n-hexane (25C+2C) 50ml each, soak for 2 hours, and use the same batch of 4% acetic acid solution and 65% alcohol solution. , n-hexane is used as the blank liquid, and the color of the soaking liquid should not be too deep.

In short, eye drop bottles are special packaging for ophthalmic drugs, and their quality and safety are crucial to the efficacy of the drugs and the health of patients. Conducting decolorization tests is an important measure to ensure drug quality and medication safety. It is also an important guarantee to improve product quality and safety and ensure medication safety for ophthalmic patients.

Why eye drops bottle can only be used for four weeks after opening

 Eye drops occupies an important position in ophthalmic drugs and are a very common type of drug. Any medicine has a validity period. The validity period of eye drops is generally 1-3 years. If the eye drops bottle is opened, the validity period of the medicine is only four weeks.

eye dropper bottle

The 1-3 year validity period marked on the eye drop bottle packaging refers to the time when the package is unopened. The "People's Republic of China Pharmacopoeia" stipulates that "ophthalmic preparations can be used for up to 4 weeks after being used", even if the drug is still within the validity period. Inside, the eye drops can only be used for up to 4 weeks after opening.

This is because once the eye drops are opened, they are easy to come into contact with microorganisms and tears during storage and use, leading to drug contamination. Under normal circumstances, each eye drop will be available after opening in the manual [Precautions] Maximum time used. Some drugs can be used for less than 4 weeks after opening, and the specific instructions shall prevail. Patients are advised to indicate the opening time on the package after opening the eye drops to avoid expiration and deterioration.

Of course, there are some special cases. If it is a small package of eye drops without preservatives, it will not have any resistance to bacteria and viruses floating in the air after opening. Each small bottle is only used for one time. Open the eye drops bottle After that, it can only be used once, and it needs to be discarded after the medication is finished

Humanized design of eye drop bottle

 Eye drop bottle is a special pharmaceutical packaging for eye drops. With the continuous changes in market demand, on the basis of satisfying functional design, humanized design has gradually become an important way for eye drop bottle manufacturers to improve their product competitiveness.

eye dropper bottle

Humanized design is a design that pays attention to the needs of human nature. From the perspective of consumers, humanized design starts from the perspective of ergonomics to make products conform to people's daily use habits. Eye drops directly contact the eyes, which is a high-risk route of administration. The humanized design of the eye drops bottle can increase the comfort and convenience of the route of administration.

The humanized design of the eye drop bottle is first reflected in the selection of materials. The eye drops generally need to be squeezed gently by hand when administering, so the material of the bottle should not be too hard, which is not conducive to the export of the liquid. Among many plastic materials, low-density polyethylene with good flexibility has become the best choice for eye drop bottle materials.

The humanized design of the eye drop bottle is also reflected in the volume of its packaging. Generally, the eye drop needs to be used up within four weeks after it is opened and cannot be used after it expires. Therefore, the packaging capacity of the eye drop bottle is mostly 5ml or 10ml, and the specific capacity will be calculated according to the method of use of the liquid medicine to avoid waste due to excessive amount of liquid medicine due to expiration.

The humanized eye drop bottle design not only improves the market competitiveness of the product, but also the key for enterprises to win in the fierce market competition. As humanized products are gradually being favored by the market, the production and design of humanized products has become every An important direction for an enterprise in product design.

Test requirements for easy oxides of eye drop bottles

 Pharmaceutical packaging can protect medicines from environmental influences and maintain the original properties of medicines, facilitating their storage, transportation and use. Eye drop bottles are commonly used packaging for ophthalmic drugs, and their quality directly affects the health and safety of patients. In its quality standards, there are many test items involved, and easy oxide is a very important one.

LDPE eye dropper bottle

Easily oxidized substances refer to substances that are prone to chemical reactions with oxygen in ordinary environments. The common ones are metals that are prone to rust. In the pharmaceutical packaging industry, they generally refer to substances that are prone to oxidation reactions with oxygen, such as organic matter, reducing agents, Sulfur, phosphorus, etc. The control of easy oxides is of great significance to ensure the quality of the drug within the validity period, prevent the chemical reaction between the precipitated reducing substances and the drug, and affect the efficacy and safety of the drug.

For the detection of easy oxides, there are specific requirements in YBB20072012 "Low Density Polyethylene Medical Eye Drop Bottles": a precise amount of 20mL of the test solution, precise addition of 20mL of potassium permanganate titrant (0.002mol/L) and Dilute sulfuric acid 1mL, boil for 3 minutes, quickly cool, add 0.1g potassium iodide, place in a dark place for 5 minutes, titrate with sodium thiosulfate titrant (0.01mol/L) to light brown, and then drop 5 drops of starch indicator solution Titrate to colorless, take another blank solution of water and operate in the same way. Do a blank test at the same time. The difference between the two consumption of sodium thiosulfate titrant should not exceed 1.5mL.

The eye drop bottle is used as a pharmaceutical package that directly contacts the eye. If the easy oxide exceeds the standard, it will cause the deterioration of the medicine and affect the patient's eye health. The quality and safety of pharmaceutical packaging materials and their compatibility with drugs have a very important impact on drug safety. In order to protect people's drug safety, manufacturers of pharmaceutical packaging materials should pay attention to their quality control.

Eye drop bottle requirements for appearance

 The main function of medicine packaging is to protect the safety of medicines, and the appearance of the packaging often determines a person's first impression and whether it will produce purchase behavior. The eye drop bottle is a special package for eye drops. Its shape is small and easy to carry. For its appearance, there are also relevant standards in the industry.

eye dropper bottle

Details determine success or failure, especially for eye drop bottles. With the prevalence of electronic products, the number of people with eye diseases such as eye fatigue and dry eyes has increased sharply, and the sales of eye drops have also increased. For some mild symptoms of eye discomfort, most people choose to go to the pharmacy to buy drugs for relief. The appearance of the eye drop bottle is the first step for consumers to understand the product. The buyer’s buying behavior has a direct impact, which greatly compromises the brand image.

According to the YBB20072012 "Low Density Polyethylene Medical Eye Drop Bottle" standard, the appearance of the bottle should meet the following requirements: Take an appropriate amount of this product, and look at it directly at a distance of 60cm in bright natural light. The thickness should be uniform, the surface should be smooth, the color should be uniform, there should be no bumps, the inner wall of the bottle should be smooth, and there should be no easily falling off. The threads of the bottle mouth and cap are clear and smooth.

The significance of the eye drop bottle is to make it convenient for consumers to use, to ensure the efficacy of eye drops, and to facilitate logistics and transportation. The appearance inspection is only one aspect of the various inspection standards. Good packaging must not go wrong in all aspects of material, processing technology, sterilization, etc. Each process must be interlocked and strict quality standards can be produced to produce high-quality eye drop bottles.

Eye drop bottle requirements for appearance

The main function of medicine packaging is to protect the safety of medicines, and the appearance of the packaging often determines a person's first impression and whether it will produce purchase behavior. The eye drop bottle is a special package for eye drops. Its shape is small and easy to carry. For its appearance, there are also relevant standards in the industry.

eye dropper bottle

Details determine success or failure, especially for eye drop bottles. With the prevalence of electronic products, the number of people with eye diseases such as eye fatigue and dry eyes has increased sharply, and the sales of eye drops have also increased. For some mild symptoms of eye discomfort, most people choose to go to the pharmacy to buy drugs for relief. The appearance of the eye drop bottle is the first step for consumers to understand the product. The buyer’s buying behavior has a direct impact, which greatly compromises the brand image.

According to the YBB20072012 "Low Density Polyethylene Medical Eye Drop Bottle" standard, the appearance of the bottle should meet the following requirements: Take an appropriate amount of this product, and look at it directly at a distance of 60cm in bright natural light. The thickness should be uniform, the surface should be smooth, the color should be uniform, there should be no bumps, the inner wall of the bottle should be smooth, and there should be no easily falling off. The threads of the bottle mouth and cap are clear and smooth.

The significance of the eye drop bottle is to make it convenient for consumers to use, to ensure the efficacy of eye drops, and to facilitate logistics and transportation. The appearance inspection is only one aspect of the various inspection standards. Good packaging must not go wrong in all aspects of material, processing technology, sterilization, etc. Each process must be interlocked and strict quality standards can be produced to produce high-quality eye drop bottles.

Application of eye drop bottle in common ophthalmology medicine

 The prevalence of electronic products has made eye diseases more and more common in our lives. Common eye diseases include glaucoma, cataracts, mydriasis, dry eye, sty, bacterial conjunctivitis, etc. The common drugs used to treat eye diseases are mostly eye drops. Therefore, eye drop bottles are also widely used in common ophthalmology drugs.

eye dropper bottle

Data show that from 2013 to 2017, the size of my country's ophthalmology market increased from 46.7 billion yuan to 86.6 billion yuan, with an average annual compound growth rate of 16.7%. With the increase in the incidence of ophthalmology, the upgrading of ophthalmic treatment technology, and the improvement of patient diagnosis and treatment awareness, the scale of my country's ophthalmology market is expected to continue to grow at a growth rate of about 14% between 2018 and 2022.

There are tablets for the treatment of ophthalmic diseases, such as: latanoprost, diclofinamide, zhangyanming tablets, scopolamine, dehydrocholic acid tablets, voriting tablets, etc.; there are also cream drugs, such as dementia Eye ointment, tetracycline ointment, yellow mercury oxide ointment, etc., among which there are many kinds of eye drops, such as timolol, clonidine, chlortetracycline, rifampicin, chloramphenicol, sodium sulfacetamide, Shaoyanning, Xiaolaiwei, sodium hydroxymethylcellulose, phthalazin, phthalazin, etc., almost every kind of eye disease treatment medicine has eye drops. Therefore, in the ophthalmic medicine packaging, eye drops Bottles occupy a large market.

With the increase in ophthalmological diseases, the market demand for ophthalmic drugs such as eye drops is also increasing. On the whole, the application of eye drop bottles in common ophthalmic drugs packaging will become more common.

Application of eye drop bottle in common ophthalmology medicine

 The prevalence of electronic products has made eye diseases more and more common in our lives. Common eye diseases include glaucoma, cataracts, mydriasis, dry eye, sty, bacterial conjunctivitis, etc. The common drugs used to treat eye diseases are mostly eye drops. Therefore, eye drop bottles are also widely used in common ophthalmology drugs.

eye dropper bottle

Data show that from 2013 to 2017, the size of my country's ophthalmology market increased from 46.7 billion yuan to 86.6 billion yuan, with an average annual compound growth rate of 16.7%. With the increase in the incidence of ophthalmology, the upgrading of ophthalmic treatment technology, and the improvement of patient diagnosis and treatment awareness, the scale of my country's ophthalmology market is expected to continue to grow at a growth rate of about 14% between 2018 and 2022.

There are tablets for the treatment of ophthalmic diseases, such as: latanoprost, diclofinamide, zhangyanming tablets, scopolamine, dehydrocholic acid tablets, voriting tablets, etc.; there are also cream drugs, such as dementia Eye ointment, tetracycline ointment, yellow mercury oxide ointment, etc., among which there are many kinds of eye drops, such as timolol, clonidine, chlortetracycline, rifampicin, chloramphenicol, sodium sulfacetamide, Shaoyanning, Xiaolaiwei, sodium hydroxymethylcellulose, phthalazin, phthalazin, etc., almost every kind of eye disease treatment medicine has eye drops. Therefore, in the ophthalmic medicine packaging, eye drops Bottles occupy a large market.

With the increase in ophthalmological diseases, the market demand for ophthalmic drugs such as eye drops is also increasing. On the whole, the application of eye drop bottles in common ophthalmic drugs packaging will become more common.

Comparison of safety items of eye drop bottles at home and abroad

 With the rapid increase in the demand for eye use, eye drops have become a must-have item for many people. As a high-risk route of administration, eye drops have very strict pharmaceutocal packaging requirements. There are differences in the standards for eye drop bottles at home and abroad. The differences in safety items are mainly reflected in clarity, burning residue, N-ethane non-volatile matter, easy to oxidize, and eye irritation test.

eye dropper bottle

Compared with foreign pharmacopoeias, some items in the YBB standard have higher requirements, such as heavy metals, n-ethane nonvolatiles, ultraviolet absorbance, etc., adding biological test items such as microbial limit, sterility, abnormal toxicity, and eye irritation tests. According to the relevant requirements of the 2015 edition of the Chinese Pharmacopoeia, eye drops should be sterile products. Through these items, the degree of microbial contamination of the drug packaging materials can be checked. In addition, the preclinical safety evaluation of ophthalmic drugs must first evaluate the ocular irritation; therefore, in order to investigate the toxicity introduced during the production process, it is necessary to detect the ocular irritation.

In the ignition residue inspection items, the YBB standard stipulates different limit requirements based on the two types of sunscreen and no sunscreen, which is more reasonable than the United States Pharmacopoeia. In terms of easy oxide detection, the content specified in the YBB standard shall not exceed 1.5ml, which is too loose compared with the 0.5ml regulation in the European Pharmacopoeia.

Although there are certain differences in individual test items, there is no doubt about the degree of attention paid to the quality of eye drop bottles at home and abroad, and there is room for improvement in the improvement of standards.

Eye drop bottle purchase to control these points

 Eye drops are common drugs for the treatment of eye diseases. As packaging materials for direct contact with drugs, the quality of eye drops bottles is the focus of attention of pharmaceutical companies. At present, there are many types of pharmaceutical packaging materials. How to choose high-quality and suitable eye drop bottles has become the key to many pharmaceutical companies to improve their product competitiveness.

5ml eye dropper bottle

The eye drop bottle is composed of a bottle cap, a bottle body and a bottle mouth. Due to the high reusability, the torque of the bottle cap will directly affect the tightness of the package. Pharmaceutical companies should fully consider this factor when choosing eye drop bottles. . According to the regulations of "Low Density Polyethylene Medical Eye Drop Bottle", when the bottle cap is twisted at 55-80Ncm, the bottle mouth and cap should match properly, and the teeth should not be slippery.

Secondly, consider the tightness of the eye drop bottle. The detection method is as follows: take a few of this product, first open the bottle, and then tighten the cap (use a force wrench to tighten the bottle and cap with a torque of 55-80Ncm, and place it in Add a baffle to the container with an air extraction device, immerse it with water, and vacuum to a vacuum of 20kPa and maintain it for 2 minutes. There should be no water or bubbling in the bottle.

Eye drops are in direct contact with the eyes, which is a high-risk route of administration. Under certain conditions, plastic packaging will migrate some of the substances contained in it to the contents, which may trigger a reaction to the contents. Therefore, the eye drops bottle Non-volatiles detection is very important. Detection method: Precisely measure 50.0ml each of the test solution and the blank solution and place them in an evaporating dish with constant weight. After evaporating to dryness in a water bath, dry to constant weight at 105°C. The difference between the two should not exceed 5.0mg.

In summary, the quality of eye drop bottles is related to the effectiveness and safety of drugs. Cap torque, tightness, and non-volatile detection are several factors that pharmaceutical companies should focus on when choosing packaging. A powerful means to control packaging quality to ensure drug safety and improve product competitiveness.

Eye drop bottle purchase to control these points

 Eye drops are common drugs for the treatment of eye diseases. As packaging materials for direct contact with drugs, the quality of eye drops bottles is the focus of attention of pharmaceutical companies. At present, there are many types of pharmaceutical packaging materials. How to choose high-quality and suitable eye drop bottles has become the key to many pharmaceutical companies to improve their product competitiveness.

5ml eye dropper bottle

The eye drop bottle is composed of a bottle cap, a bottle body and a bottle mouth. Due to the high reusability, the torque of the bottle cap will directly affect the tightness of the package. Pharmaceutical companies should fully consider this factor when choosing eye drop bottles. . According to the regulations of "Low Density Polyethylene Medical Eye Drop Bottle", when the bottle cap is twisted at 55-80Ncm, the bottle mouth and cap should match properly, and the teeth should not be slippery.

Secondly, consider the tightness of the eye drop bottle. The detection method is as follows: take a few of this product, first open the bottle, and then tighten the cap (use a force wrench to tighten the bottle and cap with a torque of 55-80Ncm, and place it in Add a baffle to the container with an air extraction device, immerse it with water, and vacuum to a vacuum of 20kPa and maintain it for 2 minutes. There should be no water or bubbling in the bottle.

Eye drops are in direct contact with the eyes, which is a high-risk route of administration. Under certain conditions, plastic packaging will migrate some of the substances contained in it to the contents, which may trigger a reaction to the contents. Therefore, the eye drops bottle Non-volatiles detection is very important. Detection method: Precisely measure 50.0ml each of the test solution and the blank solution and place them in an evaporating dish with constant weight. After evaporating to dryness in a water bath, dry to constant weight at 105°C. The difference between the two should not exceed 5.0mg.

In summary, the quality of eye drop bottles is related to the effectiveness and safety of drugs. Cap torque, tightness, and non-volatile detection are several factors that pharmaceutical companies should focus on when choosing packaging. A powerful means to control packaging quality to ensure drug safety and improve product competitiveness.

Basic requirements for pharmaceutical packaging

 Pharmaceutical packaging is a container used to store medicines, with different materials and shapes. The main function is to protect medicines in circulation and maintain the safety of medicines within the validity period. The quality of the packaging is related to the efficacy of the medicine and will have a direct impact on the patient's condition. So what should pharmaceutical companies pay attention to when it comes to pharmaceutical packaging?

eye dropper bottle

1. The choice of pharmaceutical packaging should be based on the in-depth knowledge of pharmaceutical companies on medicines. Only by combining the characteristics of medicines to choose the right packaging can better protect the quality of medicines and maintain good efficacy.

2. Make sure that the pharmaceutical packaging complies with the relevant regulations of the national and professional standards.

3. Under normal storage and transportation conditions, medical packaging must ensure that qualified drugs do not deteriorate within the validity period.

effervescent tablet tube

4. Medical packaging (including transportation packaging) must be sealed, sealed, sealed, or used with anti-theft caps, bottle cap sleeves, etc. The label must be affixed and adhered firmly, and must not be put into the bottle together with the drug; any damaged seal, label, packaging container, etc. shall not be shipped or sold.

5. The transport packaging of various drugs must meet the requirements of their physical and chemical properties. All medicines that are afraid of freezing and heat are shipped to different regions in different seasons, and corresponding measures to prevent cold or heat must be taken.

child proof bottle

6. The storage and transportation pictorial signs of drug transport packaging, and the packaging signs of dangerous goods, etc., must comply with national standards and relevant regulations.

Pharmaceutical packaging is nothing trivial. When pharmaceutical companies do a good job in drug research and development, only by choosing qualified and high-quality packaging can they better protect drugs and contribute to human health.

Eye drop bottle purchase to control these points

 Eye drops are common drugs for the treatment of eye diseases. As packaging materials for direct contact with drugs, the quality of eye drops bottles is the focus of attention of pharmaceutical companies. At present, there are many types of pharmaceutical packaging materials. How to choose high-quality and suitable eye drop bottles has become the key to many pharmaceutical companies to improve their product competitiveness.

5ml eye dropper bottle

The eye drop bottle is composed of a bottle cap, a bottle body and a bottle mouth. Due to the high reusability, the torque of the bottle cap will directly affect the tightness of the package. Pharmaceutical companies should fully consider this factor when choosing eye drop bottles. . According to the regulations of "Low Density Polyethylene Medical Eye Drop Bottle", when the bottle cap is twisted at 55-80Ncm, the bottle mouth and cap should match properly, and the teeth should not be slippery.

Secondly, consider the tightness of the eye drop bottle. The detection method is as follows: take a few of this product, first open the bottle, and then tighten the cap (use a force wrench to tighten the bottle and cap with a torque of 55-80Ncm, and place it in Add a baffle to the container with an air extraction device, immerse it with water, and vacuum to a vacuum of 20kPa and maintain it for 2 minutes. There should be no water or bubbling in the bottle.

Eye drops are in direct contact with the eyes, which is a high-risk route of administration. Under certain conditions, plastic packaging will migrate some of the substances contained in it to the contents, which may trigger a reaction to the contents. Therefore, the eye drops bottle Non-volatiles detection is very important. Detection method: Precisely measure 50.0ml each of the test solution and the blank solution and place them in an evaporating dish with constant weight. After evaporating to dryness in a water bath, dry to constant weight at 105°C. The difference between the two should not exceed 5.0mg.

In summary, the quality of eye drop bottles is related to the effectiveness and safety of drugs. Cap torque, tightness, and non-volatile detection are several factors that pharmaceutical companies should focus on when choosing packaging. A powerful means to control packaging quality to ensure drug safety and improve product competitiveness.

What are the differences between domestic and foreign standards for medicinal eye drop bottles

 Pharmaceutical packaging is a powerful guarantee to ensure the quality of medicines and maintain their efficacy, and is an indispensable part of the circulation of medicines. As a container that directly contacts drugs, drug packaging requires industry standards to regulate its production quality, and eye drop bottles are no exception. Eye drops are a high-risk route of drug administration, and their packaging requirements are more stringent. So what are the differences between domestic and foreign standards for eye drop bottles?

eye dropper bottle

At present, the standards implemented for low-density polyethylene medical eye drops bottles are the national drug packaging (container) material standards promulgated by the State Food and Drug Administration, YBB00062000 and the 2015 version of the national drug packaging material standard YBB0062002-2015. This standard is only applicable For multi-dose eye drop bottles, the standard for single-dose eye drop bottles is mostly corporate standards. In the domestic standard, the appearance, tightness, dripping volume, dissolution test, clarity, clarity, easy oxidation, PH value change, heavy metals, non-volatile matter, ignition residue, and decolorization test of eye drop bottles , Microbial limits, etc. have specific requirements.

Although the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) do not directly stipulate the quality standards of eye drop bottles, there are relevant regulations for polyethylene plastic packaging materials in the general rules. Compared with China's eye drop bottle standards, the United States and European Pharmacopoeia have no special requirements on the amount of eye drop bottle dripping, pH change, and eye irritation test. However, there are no special requirements for aluminum, chromium, titanium, vanadium, zinc, and zirconium. The content has standard requirements, and other items are not much different.

Through the comparison of the quality standards of eye drop bottles at home and abroad, it is not difficult to see that the domestic packaging standards are already very standardized and can fully meet the packaging needs of the domestic pharmaceutical industry. Among them, there are many pharmaceutical packaging materials companies that are going to the international stage. It is believed that with the continuous innovation and improvement of my country's packaging processing technology, the domestic pharmaceutical packaging standards will be in line with international standards and help the internationalization of Chinese pharmaceutical companies' brands.

Pharmaceutical packaging industry reshuffle

 The General Office of the State Council issued a document requesting to promote the normalization and institutionalization of centralized drug procurement, guide drug prices to return to a reasonable level, and reduce the burden of drug use by the masses. Data shows that as of 2020, the actual procurement volume of centralized drug procurement has reached 2.4 times the agreed procurement volume, and the overall cost savings have exceeded 100 billion yuan.

effervescent tablet tube

Procurement with quantity means that the required quantity of procurement will be announced in the bidding announcement. In the bidding process, in addition to the price, you must also consider whether you can afford the corresponding production energy. In the past, drug bidding only focused on price, not quantity. The winning bidder still needed to work in hospitals to promote the use of medicines; while for volume procurement, the sales of medicines were promised at the same time as the bidding to ensure that they would be used up within a few months. This procurement method can achieve the effect of volume-for-price through market-based bidding among enterprises and reduce the price of drugs purchased.

child proof bottle

For pharmaceutical companies, if the market share is not too high before winning the bid, the shortlisted purchase list can quickly increase sales, and sales will also increase simultaneously, which has the effect of trading price for volume. But if the market share was already high before, the increase in volume may not be enough to make up for the price loss. On the whole, mass procurement has had a huge impact on the entire industry chain of drug research and development, production, circulation, and use. With the continuous deepening and improvement of mass procurement in the pharmaceutical industry, the pharmaceutical market is about to face a major industry reshuffle.

eye dropper bottle

The pharmaceutical industry has started a big wave of sand-washing mode. As a direct contact with drugs, the pharmaceutical packaging industry, which has an important impact on drug quality and drug safety, will also be affected. Good pharmaceutical packaging is critical in meeting regulatory requirements, increasing brand effect, and helping patients comply with medication regulations. Only pharmaceutical packaging can be used as a carrier to enter the circulation market. The market effect of the survival of the fittest in the pharmaceutical industry will inevitably lead to a new round of integration in the pharmaceutical packaging industry, and pharmaceutical packaging material manufacturers without strength will be eliminated.

Microbial Limit Test of Eye Drop Bottle

 The microbial limit inspection method is a method to inspect the degree of microbial contamination of non-specified sterilized preparations and their raw materials and auxiliary materials. The inspection items include the number of bacteria, molds, yeasts and control bacteria. At present, most pharmaceutical packaging has specific regulations on microbial limits, and eye drop bottles used as eye medications are no exception. So, how to detect the microbial limit of the eye drop bottle? How is it required in relevant industry standards?

eye dropper bottle

The eye drop bottle consists of a bottle body, an inner stopper and a bottle cap. The specification is generally 5ml-100ml, and the material is mostly low-density polyethylene.

According to the relevant standards of "YBB20072012 Low Density Polyethylene Medical Eye Drop Bottles", the microbial limit detection follows the following methods and standards: Take several test bottles, add 1/2 nominal volume of sodium chloride injection, and tighten the cap , Shake for 1 minute to get the test solution. The test solution shall be tested in accordance with the law after membrane filtration (Chinese Pharmacopoeia 2010 Edition Two Appendix XIJ). Bacteria must not exceed 100cfu per bottle, molds and yeasts must not be detected, Staphylococcus aureus must not be detected, and Pseudomonas aeruginosa must not be detected. Check out.

Whether the microbial limit meets the standard is related to the quality of the eye drop bottle. If the unqualified product is used in the medicine, it will not only pollute the medicine, but also seriously affect the health of the patient. The importance of pharmaceutical packaging cannot be ignored, and pharmaceutical packaging material manufacturers should strictly control the quality to protect the safety of drugs.

Principles of ethylene oxide sterilization for eye drop bottles

 Eye drops refer to sterile liquid preparations such as clear solutions or suspensions for eye drops made of medicines and excipients to prevent or diagnose eye diseases. As a kind of sterile medicine, its requirements for eye drop bottles are very strict. Whether the sterilization is thorough is of great significance to the efficacy of the medicine and the health of the patient.

10 ml eye dropper bottle

Among many sterilization methods, ethylene oxide sterilization is the most commonly used sterilization method for eye drop bottles. As a broad-spectrum sterilant, ethylene oxide can kill various microorganisms at room temperature, including spores, tubercle bacilli, bacteria, viruses, fungi, etc., mainly destroying the metabolic process of bacteria. This kind of sterilization method does not damage the sterilized items and has strong penetrating power. Most items that are not suitable for general methods can be sterilized and sterilized by ethylene oxide, such as electronic instruments, optical instruments, books, documents, Dialyzers and disposable medical supplies, etc.

Ethylene oxide can be sterilized with 100% pure ethylene oxide or a mixture of ethylene oxide and carbon dioxide, and the use of freon is prohibited. Excessive exposure to ethylene oxide can cause burns and irritation to the patient. Therefore, when using this sterilization method, the residue should also be investigated. The amount of the residue is related to the sterilized article materials, sterilization parameters, packaging materials and sizes, loading capacity, analytical parameters, etc. Related, the measurement method is based on YBB60202012.

Ethylene oxide sterilization is a widely used sterilization method for plastic pharmaceutical packaging materials. The sterilization method used for eye drop bottles depends on the properties of the drug and the specific needs of pharmaceutical companies.

Increased demand for ophthalmic treatment

 The eye is one of the important sensory organs of the human body. With the changes in technology and lifestyle, the incidence of various eye diseases is gradually increasing. Relevant data shows that the number of myopia in Chinese adolescents is estimated to be about 100 million, the number of adult myopia is 450 million, and the number of macular fundus diseases is about 64 million. The incidence of various eye diseases such as cataract, glaucoma, and dry eye is increasing year by year. The sharp increase in demand for treatment has led to rapid growth in the ophthalmology market.

eye dropper bottles

According to statistics from the China Commercial Industry Research Institute, the scale of China's ophthalmology market has grown from 46.77 billion yuan in 2013 to 97.97 billion yuan in 2018, with a compound annual growth rate of 17%. With the upgrading of high-tech, consumption upgrades, increased ocular morbidity and increased patient self-diagnosis awareness, it is estimated that the size of the Chinese ophthalmology market has exceeded 100 billion yuan, and the compound annual growth rate of the market size in the next five years is expected to remain at 13%- Around 15%. The most common medicine to treat eye diseases is eye drops, and the large-scale growth of the ophthalmology market will inevitably stimulate the development of the packaging industry chain for eye medicines such as eye drop bottles.

The pharmaceutical packaging of medicines is an important means of competition for medicines, especially OTC products, especially for eye drop bottles. The overall appearance and practicality of the eye drop bottle will affect the sales of the drug. The scale of the ophthalmology market of hundreds of billions is both an opportunity and a challenge. How to seize the industry opportunities and occupy a place in the fierce market competition is worthy of consideration by many pharmaceutical companies.