how to choose the desiccant for pharmaceutical packaging

 

caps with silica for effervescent tablet tubes

How to choose the desiccant like silica gel or molecular sieve for pharmaceutical packaging.

No matter you choose silica gel or molecular sieve,the first step is that confirm the dosage of the desiccant which you will use in the effervescent tube. You need confirm the size of effervescent tube,then according to the size,confirm the dosage of the desiccant.In generally,the dosage of effervescent tube is 2.1g and 3.9g. 

Then you need research your target market,your target market whether permit use molecular sieve,because some countries don't permit use molecular sieve, the temperature of storing environment can influence the moisture absorption ability of silica gel and molecular sieve.The most suitable temperature of silica gel is 20~32°C and 60~90°C.

ICH drug stability research evaluation

 

The purpose of the ICH drug stability study is to establish, based on the test of at least three batches of drug substance stability and evaluation information (including physical, chemical, biological and microbiological tests with appropriate results), the next period of retesting is applicable to all batches.

The data may show little degradation and little variability, so it is obvious from looking at the data that the required retest period will be approved. In this case, there is usually no need for a formal statistical analysis; it is sufficient to provide justification for the omission.

One way to analyze data for quantitative attributes expected to change over time is to determine the time when the 95% one-sided confidence limit of the average curve intersects the acceptance criterion. If the analysis shows that the variability from batch to batch is small, then it is advantageous to incorporate the data into a single overall estimate. This can be achieved by first applying an appropriate statistical test (for example, rejecting the p-value of the significance level greater than 0.25) on the slope of the regression line and the zero time intercept of a single batch. If it is not suitable to combine data from several batches, the overall retest cycle should be based on the minimum time a batch is expected to remain within the acceptance criteria.

The nature of any degenerate relationship will determine whether the data should be converted to linear regression analysis. Generally, this relationship can be expressed by linear, quadratic, or cubic functions on arithmetic or logarithmic scales. Statistical methods should be used to test the goodness of fit of the data from all batches and combined batches (where appropriate) to the assumed degradation line or curve.

If necessary, limited extrapolation of real-time data of long-term storage conditions beyond the observation range can be performed at the time of approval to extend the retest period. This proof should be based on the known degradation mechanism, test results under accelerated conditions, goodness of fit of any mathematical model, batch size, existence of supporting stability data, etc. However, this extrapolation assumes that the same degradation relationship will continue to apply outside the observed data.

Any evaluation should include not only determination, but also the level of degradation products and other appropriate attributes.

how to choose the desiccant for pharmaceutical packaging

 

caps with silica for effervescent tablet tubes

How to choose the desiccant like silica gel or molecular sieve for pharmaceutical packaging.

No matter you choose silica gel or molecular sieve,the first step is that confirm the dosage of the desiccant which you will use in the effervescent tube. You need confirm the size of effervescent tube,then according to the size,confirm the dosage of the desiccant.In generally,the dosage of effervescent tube is 2.1g and 3.9g. 

Then you need research your target market,your target market whether permit use molecular sieve,because some countries don't permit use molecular sieve, the temperature of storing environment can influence the moisture absorption ability of silica gel and molecular sieve.The most suitable temperature of silica gel is 20~32°C and 60~90°C.

Covid-19 technical support to solve research and development problems

 The Covid-19 is composed of a complete virus, and its pathogenicity is inactivated through physical and chemical methods, while still maintaining all or part of the immunogenicity of the virus. The candidate vaccine is prepared through inactivation verification and purification processes. After vaccination, the viral antigen can stimulate the body to produce an immune response and produce antibodies to achieve a protective effect. my country has a good foundation for research and development of inactivated vaccines. At present, many domestic research institutions and companies are intensively developing new crown inactivated vaccines.

COP vials

"The vaccine inspection cycle takes longer than other drugs." said Xiang Jinzhong, chief reviewer of the Department of Pharmacy of Biological Products of the Center for Drug Evaluation. For this reason, the State Drug Administration's special affairs office supports applicants in advance The hospital conducts inspection and quality standard review of inoculation sub-banks, clinical samples, etc., and does a good job of docking with the China Inspection Institute on quality review and other related work to save vaccine inspection time.

In accordance with the requirements of emergency inspections, the China National Inspection Institute intervened in vaccine research and development in advance. For new vaccines developed in emergency situations, the task of communicating vaccine quality standards and inspection-related issues with the research and development unit has been several times heavier than usual.

effervescent tablet packaging

Undertaking the inspection task of the new crown inactivated vaccine is the Li Changgui team of the respiratory virus vaccine room of the National Inspection Institute and the technical backbones such as Xu Kangwei and Quan Yaru. "There are four companies involved in the research and development of inactivated vaccines, and the characteristics and conditions of each research and development product are different. Therefore, the quality standards and inspection methods of each product need to be more targeted." Li Changgui said that the team used technical reserves to Prepared and purified goat anti-new crown virus, goat anti-new crown virus Spike protein, rabbit anti-new crown virus, rabbit anti-new crown virus Spike protein, rabbit anti-new crown virus Spike protein RBD region and other antibodies, and provided them to many inactivated vaccine manufacturers to establish The antigen content detection method has laid a foundation for advancing the process of vaccine research and development and ensuring vaccine quality.

The virus seed is the basis for the development and preparation of vaccines, and the quality of the virus seed directly affects the safety and effectiveness of the vaccine. Li Changgui introduced that because there is no high school and titer antiserum, companies cannot perform virus identification, mycoplasma, and foreign factor testing. Therefore, the team adopted multiple approaches and multiple immunization strategies, and took the lead in preparing high-titer antiserum from SPF rabbits, which was used in the detection of virus species used in production by all domestic enterprises, solving the problem of virus species quality control. ——Enable enterprises to accelerate the conditions for applying for registration and inspection.

The in vivo efficacy test of the vaccine directly reflects the effectiveness of the vaccine. However, this experiment needs to be completed in a P3 laboratory (three-level biosafety protection laboratory), and the number of domestic P3 laboratories is far from meeting the needs of many R&D teams . "At that time, the detection methods established in the early stages of all companies needed to be tested by virus neutralization experiments, which had a high biosafety risk. The team and the company jointly tackled key problems and tested total antibodies after immunizing mice, establishing that no P3 is required. In vivo efficacy testing methods in laboratories.” He said that this testing method makes vaccine development progress no longer restricted by the number of laboratories.

Layout in advance and continuously solve multiple problems, laying the foundation for emergency inspection. On March 15, Beijing Kexing Zhongwei Biotechnology Co., Ltd. sent the first batch of inactivated vaccines for the new crown, and the China National Inspection Institute quickly launched the inspection. Take the respiratory virus vaccine room of the National Inspection Institute as an example. Up to now, 36 batches of new crown inactivated vaccines, 18 batches of original solutions and 4 batches of placebo have been tested by 4 R&D units, accounting for 132 batches of vaccines and For 44% of the original solution and placebo/control, 42 inspection reports have been issued, creating a prerequisite for China's new crown inactivated vaccine to enter clinical trials in the world.

(Source: National Center for Drug Administration and Evaluation)

Which May Cause Desiccant Tube Date Error

 The reason of desiccant tube date error has been confiromed. Confirmation is not laboratory test error caused by excessive, is indeed the quality of products after exceeding the standard. The investigation phase of exceeding standard is transferred from the quality control laboratory to the production related department, and the reasons can be divided into the following three kinds:

effervescent packaging

First, deviation of non production process: deviation of test results caused by operator's failure to operate equipment or wrong material.The deviation is investigated by professionals in the quality department, the production department or the equipment management department.

sprial desiccant  closure

Second, production process deviation refers to the deviation of the inspection results caused by the defects of the production process, even if the personnel operation, equipment and materials are correct. The deviation should be investigated by professionals familiar with and familiar with the process technology.

the produce process for desiccant tube

Third, if the material itself brings the deviation, the survey is divided into two cases: first, the factory inspection deviation. First of all by the quality department and supply department investigation, receiving temporary process if there is deviation, the absence of such a material manufacturer shall notify the investigation of its production and storage process without bias, and investigate whether there is any deviation in the transport process.The two is if the factory inspection qualified, in the use or storage process deviation, should be the quality department and supply department investigation storage conditions and weighing process whether there is deviation.

The data record is clear, do not do well documented, product appearance, desiccant tube manufacturers can gain a foothold in the messy. 

What are nutraceuticals packaging

The definition of Nutraceuticals on a global stage is highly divergent. It could refer to products that range from isolated nutrients, dietary supplements, herbal medicines, functional foods, medical/ specific diets and beverages. In India, nutraceuticals and herbal medicinal products fall under the purview of different regulatory bodies, FSSAI, AYUSH or CDSCO, depending on the health claims made and ingredients used.

empty vitamin tablet tubes

The Indian nutraceuticals industry is in a growth phase, with several key drivers such as consumer awareness, emphasis on prevention over cure and clinical receptiveness, being some of them.

India also fosters a thriving market for herbal extracts. Much of the traditional medicine practised worldwide can trace its roots to India, and the country is a hot bed for cultivation of herbal plants. The herbal extracts industry is estimated at $1.3 billion, with exports accounting for a sizeable 47 per cent of sales.

India also has the unique advantage of long-standing heritage and knowledge, when it comes to traditional medicines. Equipped with local sourcing and supply of raw materials, herbal extract manufacturers have emerged as highly price competitive in the global markets and have established a strong presence as a preferred supplier in many export markets.

Xinfuda as a manufacturer for effervescent tubes, we have 20 years history.

Effervescent tube packaging

The effervescent tablet packaging is mostly plastic hollow packaging with a certain moisture-proof function, which is mainly composed of two parts, a moisture-proof cap and a tube; the bottle cap adopts an integrated design, and the built-in desiccant in the bottle cap can effectively absorb the water molecules in the package. 

effervescent tablet packaging

There is a bottle buckle, the anti-theft ring will be stuck when the moisture-proof cover is covered, and it will be replaced automatically when it is opened. The connection has been tested for 300 breakpoints, worry-free filling, easy to open; 

2, stopper spring: optional 

3, imported desiccant, the final product rate ≤ 2%, higher than the national standard 2.8; desiccant saturated moisture absorption rate at Between 24% and 26%, to ensure that the drug is kept in good condition; 

4, Germany imported equipment to produce advanced molds, constant environment production, to ensure product quality is stable; 

5, automatic desiccant filling equipment, accurate dosage, more conducive to Control the batch; the stability of the quantity of products; 

6, provide printing or pre-sticking stickers service, improve the overall effect of the product and enhance the brand value.

Plastic candy tubes and tablet technical standards

The plastic candy tubes have been gradually developed from the original common medicine bottle to a more functional and more market-oriented direction. A medicinal package suitable for effervescent preparations and test strips, used by more tableting candy brands. The package can have a controlled amount of water molecules in the package to extend the potency of the drug and the taste of the compressed candy.

effervescent tablet packaging

The technical standards for compressed candy specify the product classification, technical requirements, experimental methods, inspection rules and signs, labels, packaging, transportation, storage, and requirements for tableting. Applicable to the production, inspection and sale of candy referred to in 3.8 of SB/T 10346-2008. The compression of tablets requires the main raw materials and auxiliary sugar (white sugar should meet the requirements of GB317); liquid glucose should meet the requirements of QB/T2319; sugar alcohol should meet the requirements of industry standards. Food additives should use the food additives specified in GB2760 and should comply with the corresponding product standards. The nutrition fortifier should use the food nutrition enhancer specified in GB14880 and should meet the corresponding product standards.

Desiccant packaging principle

According to the effervescent tablet medicinal properties, the desiccant packaging principle is to place the desiccant in the cap and seal the bottle through the cap. The package has strict requirements on sealing properties, water molecule control, moisture resistance, water vapor transmission rate, and moisture content of the desiccant. The pharmaceutical packaging has achieved the purpose of absorbing water molecules by placing the desiccant in the cap, which requires the material to have good barrier properties to water molecules. Followed by the moisture content of the desiccant and the humidity of the production plant. All of these aspects will lead to the effectiveness of effervescent tablets.

    

desiccant packaging

The prescription for effervescent tablets consists of the main drug, diluent, binder, disintegrant, lubricant and other excipients. The diluents, binders, lubricants and other excipients used are the same as ordinary tablets. The appropriate variety needs to be selected according to the preparation process. Unlike ordinary tablets, the disintegrant used in effervescent tablets is an effervescent disintegrant, and the effervescent disintegrant includes an acid source and an alkali source. Commonly used acid sources are citric acid, malic acid, boric acid, tartaric acid, and rich. Horse acid, inorganic mineral acid (hydrochloric acid), etc.; commonly used alkali sources are sodium hydrogencarbonate, sodium carbonate and a mixture of the two. The ratio of acid to base has a significant effect on the preparation and stability of effervescent tablets. It is generally believed that the amount of acid exceeds the theoretical amount, which is beneficial to the stability of the effervescent tablet and the improvement of the mouthfeel.

Tubes for effervescent tablets

Tubes for effervescent tablets is a popular packaging for those who need keep away from moisture, usually effervescent tablets diameter is 27mm, of course some calciums for children need small size.

effervescent packaging

There are some size including 84mm, 96mm,99mm,133mm and 144mm height tube for different tablets, main diameter is 27mm, and also have bigger diameter like 38mm, small diameter like 21mm. We can also offer customized tube accodint to your tablets.

Tubes for effervescent tablets can keep the tube in a dry environment, there is desiccant in the caps to absorb the moisture in the tube, desiccant main adopt silica for medicine and food.

desiccant cap

Various types of medicinal silica gel desiccants form different microporous structures due to their different manufacturing methods. The chemical composition and physical structure of silica gel determine that it has many characteristics that are difficult to replace with other similar materials: high adsorption performance, good thermal stability, stable chemical properties, and high mechanical strength.

What is the effervescent tablets requirement for plastic tubes

My health awareness has gradually increased, and the requirements for further safe, effective and rational drug use are getting higher and higher. The dosage form also needs to be convenient to take, fast in effect, high in bioavailability, accurate in dose, stable in quality, and easy to carry, transport and store. drug.

effervescent tablets tubes

In order to meet this demand, "dry liquid preparation" - effervescent tablets came into being, it gathered the essence of ordinary oral tablets and liquid preparations and made up for the deficiency of both, becoming a new type of dosage that consumers love. . The predecessor forms of oral effervescent tablets are foamed soda, foaming tablets, effervescent, effervescent infusion and topical effervescent tablets.

plastic tube details

Effervescent tablets are easy to get wet products, so there are certain requirements for packaging. What are the characteristics of effervescent tube tubes at present? Significant features of effervescent tube: 

First, Anti-counterfeiting - The unique printing method completely eliminates the use of labeling and fraud by lawless elements, protects the company's interests and reputation, and reduces the cost of corporate fraud. 

Second, Safety - Install the desiccant on the effervescent bottle cap to prevent accidental eating and misuse, and to ensure user safety. 

Third, Advertising - Color printing is colorful, the label color is more vivid, friction resistant and smooth. Invisibly improve the product grade of the enterprise, highlighting the strength of the enterprise and playing a good advertising role. 

Fourth, save money - reduce equipment investment for enterprises, reduce employment, save energy by more than 70%.

spring caps producing

Desiccant Stoppers Give Tablets Dry Condition

Tubes with desiccant stoppers is a functional packaging to deal with some troubles of pharmaceutical factories. Many medicines need a dry condotion to keep their expiration date, which need the medicine packaging to deal the problem.

 

tubes with desiccant stoppers

The effervescent tubes with desiccant stoppers can deal with the moist, there are silica gel desicant and safe stopper on the cap, silica gel desiccant can absorb moist from the bottle or air, stopper is safe to store the desiccant seal.

 

spiral desiccant closure

Another cap is not only with desiccant and stopper, but also with spiral prevents tablets damaging. The desiccant stoppers can use in tubes and bottle.

How Do Effervescent Tubes Work

Today, firstly i will introduce the work principle of effervescent tubes, as a packaging supplier in China, Xinfuda has owner design team. Of course, the work principle of effervescent tubes is revelent to design team and market need.

 

effervescent tubes

First, from the surface, the inner and outer of the tubes must be smooth and vehical, the cap must has moisture proof function, which can ensure the dry condition for drugs.

Second, from the structure of the effervescent tubes, which is contained with desiccant closures and vehical tubes. Desiccant closures not only have silica gel desccant in the store, but also have spiral on the cap, above all, which ensure the drugs dry condition and undamage during the transport.

 

84mm effervescent tubes with desiccant closures

Third, the uasge of effervescent tablet tube is easy and safe, there is a gap on the cap, your hand just put there and then upwards. The ring will fall off, and the tube is open.

Effervescent Tubes with Desiccant and Stopper

Usually effervescent tablets has two years expiration date, However it is used for 12-18 month in practical application. Two main desiccant are silica and molecular, and silica is the only one met demands of FDA. Desiccant and stopper caps make the vitamin and chew healthy and dry.

 effervescent tubes

Silica of desiccant and stopper is a highly active adsorption material, It is hard, non-toxic, tasteless, non-corrosive, also strong chemical stability and thermal stability.

Silica has strong hydrophilia, at the same time has many holes with out eyes seeing on the surface of the silica gel desiccant cap, make its surface area has greatly increased, these characteristics of silica gel desiccant decided to become a good hygroscopicity of desiccant.

Do you konw what is inside the closure of effervescent vitamin C tablets

Usually we ofen drink vitamin C tablets to get vitamin supplement, and i wonder that whether you are curious about why the tablets is always dry? Whether you observe the cap of the tubes?

 

effervescent vitamin C tablets tube

Let me expose a secret, of course, i guess all of you may have guessed it. It must be influenced on the tablets packaging. Watch the packaging carefully, you will find that the closure of the effervescent vitamin tablets is special, usually there is a store on the top of cover, so are you curious what is inside of the store?

There are silica gel desiccant in the store, as is well know that in order to keep the food or medicine effectiveness we need some desiccant. However only silica gel desiccant is meet the FDA food standard. Silica gel desiccant can absorb water to offer tablets a dry enviroment, another is that desicccant in the store will not touch the tablets directly, which is beter than desiccant in bags.

 

silica gel closure

So packaging is a magical angel for medicine and food, which offer health for people, packaging is also functional.

How to test the sealing of effervescent tubes?

Is your product troubled by the following issues?

Tablets go bad due to the moist or leakage, tablets may damage by transportation and shake.

Xinfuda has rigorous test sealing system, the way of testing the tightness of the tubes and caps:

silica gel desiccant

desiccant spiral cap

Standard experiment: Sealed negative pressure instrument, under 27Kpa, 2minutes

practical test: 40Kpa, 2minutes

Result: There's no water in the bottle or there's no bubbles.

The spring can prevent tablet damage, the tablet should keep some distance from the spring:

The best condition is that the tablet on the top can touch the spring with a little pressure. Then it can prevent the tablets from shaking

Xinfuda will attend AgroFarm on Feb.6-Feb.8 in Russ

A wonderful thing tell all of you that Xinfuda will attend AgroFarm on Feb.6-Feb.8 2018 in Russ, so all our old friends,new friends and future friends can come to our booth No.:75B-G29. You can find us following the picture.

AgroFarm Booth

AgroFarm assumes a leading position as international exhibition for animal husbandry and animal breeding in Russia. We want to cooperate with foreign companies, to develop our own production. The most important fact is that despite the difficult situation, practically all renowned manufacturers came to the show. 

AgroFarm 

Xinfuda will carry with our key products to know more friends, our key products include veterinary paste syringe, vaccine vials, double neck liquid bottle, and even our pharma bottle like effervescent tubes, desiccant and stoppers, child proof cap, COP vials and so on.

Xinfuda will attend IPPE Atlanta 2018

Xinfuda will attend IPPE on Jan 30th  to Feb 1th Atlanta, and our booth number is B8825, welome to our booth.International Production & Processing Expo 2018 will bring together more than 1,200 exhibitors and 30,000 visitors in Atlanta, The trade show focuses on Innovation - bringing together buyers and sellers of the latest technology of products and services to make your business successful.

 

effervescent tubes

 

child resistant cap 

We will bring our main products in the exhibition including paste syringe, effervescent tubes, child resistant cap, reagent bottle, vaccine bottle, etc.. welcome to our booth and have more details discuss.

133mm Vitamin C Tube with Desiccant Cap Y005

133mm effervescent tubes with desiccant closure

How to choose vitamin C tube?

Vitamin C tube belongs to a special packaging in the international, which has strong professionalism. The sealed fitting of bottle body and cap is important for avoiding vitamin C tablets wetting. It is the key step for vitamin C tablet manufacturer to choose suitable packaging. Except sealing, there are also some points need to pay attention.

effervescent packaging 

First, surface: Color uniform, no damage, no oil, good match.

Second, the moisture content of the drying agent:lower than 4.8%.

Third, anti-fall: desiccant must not be dropped

Fourth, board: moisture content below 6%, no fluorescence reaction, heavy metal less than 5 parts per million.

Fifth, dissolution: heavy metals, oxides and non-volatile substances.

Sixth, microorganisms: bacteria less than 1000, mould yeast less than 100, escherichia coli may not be detected.

Seventh, abnormal toxicity should not be detected.

144mm plastic vitamin c tube

VC tablets tube has an important part is that spiral desiccant cap, spiral desiccant cap is the international univerisal cap for effervescent tablets, the structure has high requirement for mould design, even some countries can not volum production. The spiral in the cap can buffer the impact of the transport process, thus protecting fragile effervescent tablets will not be damaged.

The selection of high-quality vitamin C tube will also need to analyze the strength, equipment and comprehensive quality of the manufacturers, and the high quality of the enterprise products will be stable, which will help your products to be more smooth in the competition.