European Pharmacopoeia Requirements for Biological Products Packaging

 Biological products, as an important part of the modern pharmaceutical field, cover a variety of drugs such as vaccines, blood products, monoclonal antibodies, recombinant proteins, etc. Since the nature of biological products is usually complex and sensitive to environmental factors (such as temperature, humidity, light, etc.), the selection and design of their packaging is particularly important. In order to ensure that biological products can maintain their quality, effectiveness and safety during transportation, storage and use, the European Pharmacopoeia (EP) has made detailed provisions for the packaging materials and packaging containers of biological products.

Under the EU drug regulatory system, packaging is not only to protect drugs from external contamination, but also to ensure that the stability and biological activity of drugs are not damaged. Therefore, the requirements of the European Pharmacopoeia for the packaging of biological products cover many aspects, including packaging materials, sealing, durability, and compatibility with drugs.

1. Selection and requirements of packaging materials

The European Pharmacopoeia requires that the packaging materials of biological products must meet the following basic standards:

a. Harmlessness and chemical stability

Packaging materials should be non-toxic and harmless materials to ensure that they do not chemically react with the active ingredients in the drugs or migrate harmful substances. Biological products, especially protein drugs, have high requirements for the compatibility of packaging materials. The chemical components in the packaging materials must not react adversely with the drugs to avoid degradation or loss of activity of the drugs.

Commonly used packaging materials include glass bottles and polymer bottles (such as polypropylene and polyethylene). Glass bottles are usually recommended for sensitive biological products because glass materials have good chemical stability and non-reactivity.

b. Air permeability and barrier properties

Biological products are easily affected by changes in temperature and humidity during storage and transportation, so the packaging materials must have certain barrier properties to prevent air, moisture, light or other external environmental factors from adversely affecting the drugs. For example, the sealing and moisture-proof properties of glass bottles need to meet specific standards to prevent the drugs from being affected by oxygen or moisture in the air and maintain the long-term stability of the drugs.

c. Sterility and microbial protection

For some biological products, especially injectable preparations, packaging materials must also pass sterility tests to ensure that microbial contamination is not introduced during the packaging process. The packaging of biological products usually undergoes strict sterilization treatment (such as steam sterilization, irradiation sterilization, etc.), and the packaging containers and their materials must be able to withstand this treatment process without losing performance.

2. Sealing and closure

Sealing is the key to ensure that the packaging of biological products is not affected by external pollution, air or moisture. The European Pharmacopoeia has clear requirements for the sealing of packaging, especially for glass bottles, injection bottles and other packaging containers of biological products. The sealing must be able to effectively maintain the stability of the drug during storage and transportation.

a. Sealing performance test

The sealing performance of the packaging usually needs to be verified through sealing tests, such as using gas leakage tests, liquid leakage tests and other methods to ensure that the drug can remain stable for a long time in a sealed container without being affected by the outside world.

b. Prevent external contamination

Biological product packaging also needs to design a reasonable closed system to prevent external contaminants (such as microorganisms, dust, etc.) from entering the drug container. This is especially important for vaccines, antibody preparations, etc., because any external contamination may cause the drug to fail or cause adverse reactions.

3. Durability and drop resistance

The packaging containers of biological products need to have high drop resistance to prevent damage or leakage during transportation. Especially for biological products such as vaccines that are distributed on a large scale, their packaging needs to be able to withstand severe vibrations, collisions and other external impacts during transportation.

The European Pharmacopoeia stipulates that packaging containers should be able to remain intact under daily transportation and storage conditions, and will not leak or break due to changes in the external environment. The drop resistance of packaging containers can be verified by performing drop tests.

4. Storage and transportation conditions

For the packaging of biological products, the storage and transportation environment also needs to be considered. Many biological products (such as vaccines, blood products, cell therapy drugs, etc.) need to be transported and stored in a temperature-controlled environment. The European Pharmacopoeia has strict requirements for this. The packaging container must be able to withstand different storage temperature conditions to ensure the stability of the quality of the drug throughout the circulation process.

The packaging label should clearly indicate information such as storage temperature, expiration date, and pre-use processing requirements to ensure that the drug is always in the best storage conditions throughout its life cycle.

5. Labels and logos

The labels and logos of biological product packaging must not only comply with the requirements of drug regulations, but also contain detailed product information, including but not limited to the name, ingredients, instructions for use, production batch number, expiration date, storage conditions, and other necessary warnings for use of the drug. Accurate label information is essential for the management, use, and safety of drugs and patients.

The European Pharmacopoeia stipulates that the design of labels should be concise and clear, ensuring the accuracy and readability of information to reduce the risk of errors or misuse.

The European Pharmacopoeia's requirements for biological product packaging are not only to meet the requirements of laws and regulations, but also to ensure the safety and efficacy of patients using biological products. The selection of packaging containers, material compatibility, sealing, and drop resistance all directly affect the quality and stability of drugs. Pharmaceutical companies must strictly abide by the provisions of the European Pharmacopoeia and ensure the quality of packaging at every stage from production to transportation to ensure that biological products can maintain optimal efficacy throughout their life cycle. By following these standards, the packaging of biological products can effectively reduce the risk of drug failure, contamination or damage, and provide patients with safer and more reliable treatment options.

RTU(ready to use) 2ml COP vial

Oral Syringes in Veterinary Medicine-Accurate Dosing for Animal Health

 When it comes to treating animals, precision and ease of administration are vital in ensuring effective therapy and minimizing stress for both animals and caretakers. Oral dosing syringes have become a popular tool in veterinary medicine, especially for pets and animals that may resist taking pills or have difficulty swallowing solid forms of medication. This blog explores the importance of oral syringes in veterinary medicine, including their benefits, common applications, and tips for successful use.

10ml oral dosing syringe

5ml oral dosing pipette

Why Oral Syringes are Essential in Veterinary Medicine

Unlike tablets or capsules, oral syringes allow medications to be administered in liquid form, which is often easier for animals to ingest. They help ensure accurate dosing, critical when treating animals of varying sizes and weights. From tiny kittens to larger breeds of dogs, oral syringes allow for precise adjustments in dosing that are essential to safe and effective treatment.

Additionally, many animals are unwilling to take pills, and oral syringes provide a more convenient method for both pet owners and veterinary professionals. By using an oral syringe, caregivers can administer liquid medications directly into the animal’s mouth, typically between the cheek and teeth, reducing the chance of the pet spitting out or refusing medication.

60ml HDPE dry syrup bottle

Key Benefits of Oral Syringes in Veterinary Medicine

Accurate Dosing

Oral syringes feature clear, precise markings, enabling accurate measurements based on the animal’s weight and required dosage. This accuracy helps prevent the risks associated with overdosing or underdosing, which can have serious implications for animal health, particularly in small animals or those with specific health conditions.

Suitable for Diverse Species

Oral syringes are used across many types of animals—from common pets like cats and dogs to exotic species like birds and reptiles. Many of these animals require small and highly specific doses, which syringes can easily measure and deliver.

Applications of Oral Syringes in Veterinary Medicine

PET amber bottle

Oral syringes serve a variety of purposes in veterinary care. Some common uses include:

Medication Administration: Oral syringes are used to give antibiotics, pain relievers, dewormers, and other medications that need to be administered in liquid form.

Nutritional Supplements: Some animals, particularly young, sick, or elderly pets, may need extra vitamins or minerals, which can be delivered easily through oral syringes.

Electrolyte Solutions: Oral syringes are an effective way to administer electrolyte solutions to animals experiencing dehydration, particularly when they cannot drink on their own.

Special Diets or Liquid Foods: For animals that need to be fed specially formulated diets in liquid form, oral syringes allow caregivers to deliver nutrition directly.

Types of medicine cap

 Medicine caps, or pill caps, come in a variety of types depending on their purpose, design, and the type of medication being contained. Here are some common types:

child resistant cap

1. Child-Resistant Caps (CRC)

Purpose: Designed to prevent children from accidentally opening bottles and ingesting the contents.

Mechanism: Typically require a combination of pushing down and twisting to open.

Used for: Prescription medications, over-the-counter drugs, or substances that can be harmful if ingested by children.

 

28mm child resistant  cap for liquid medicine

2. Senior-Friendly Caps

Purpose: Easier to open for elderly people or those with limited hand strength or dexterity.

Design: May be flip-top or have an easy-to-grip design, often with wider threads for better leverage.

3. Tamper-Evident Caps

Purpose: Provide visual evidence if the bottle has been opened or tampered with.

Design: Includes a band around the neck of the bottle that breaks or shows signs of damage when the bottle is opened.

Used for: Prescription medications, supplements, and over-the-counter drugs.

4. Non-Child-Resistant Caps

Purpose: Provide simple, easy access for adults.

Design: Regular screw-on caps without child-resistant features, typically used for non-hazardous substances.

5. Snap-On or Press-On Caps

Purpose: Simple to close and open by pressing the cap firmly onto the bottle.

Design: No twisting required, commonly found in some over-the-counter bottles or small containers.

6. Dropper Caps

Purpose: Allows controlled dispensing of liquid medications, often used for liquids like eye drops or oral syrups.

Design: Comes with a dropper or nozzle to control the amount of liquid dispensed.

Used for: Liquid medications, oils, and tinctures.

7. Flip-Top Caps

Purpose: Often found on liquid medications or products that require frequent opening.

Design: Includes a lid that flips open, providing easy access to the contents without removing the cap entirely.

Used for: Lotions, liquid medications, and some over-the-counter drugs.

8. Pressure-Sensitive Caps

Purpose: Used to maintain an airtight or moisture-proof seal.

Design: Seals tightly with pressure, often used for powders or substances that must remain sealed to retain their potency.

9. Screw Caps

Purpose: A simple screw-on mechanism to seal the bottle.

Design: Used for a variety of products, including vitamins and prescription medications.

desiccant cap

10. Bottle Caps with Desiccants

Purpose: Includes a small desiccant packet or material to absorb moisture and keep the contents dry.

Used for: Pills and tablets that are sensitive to moisture, like certain antibiotics or vitamins.

Different types of caps are designed to ensure that the medications are safe, secure, and convenient for the end user, depending on their needs and the type of medication.

Choosing the Right Material for Oral Syrup Bottles

 When it comes to oral syrup bottles, the choice of material is crucial for ensuring safety, efficacy, and shelf life. Here’s a closer look at the common materials used and their benefits.

Common Materials Used for Oral Syrup Bottles

PET amber bottle

PET (Polyethylene Terephthalate):

Properties: Lightweight, clear, and resistant to impact.

Benefits: PET is widely used because it is non-toxic and offers good barrier properties against moisture and oxygen, helping to preserve the syrup's integrity.

60ml HDPE dry syrup bottle

HDPE (High-Density Polyethylene):

Properties: Opaque, durable, and resistant to chemicals.

Benefits: HDPE is excellent for storing thicker syrups as it doesn’t absorb moisture. It’s also more affordable and recyclable, making it an eco-friendly option.

Glass:

Properties: Heavy, impermeable, and non-reactive.

Benefits: Glass provides a premium option that ensures maximum protection from external contaminants. It also doesn’t leach chemicals, making it ideal for sensitive formulations.

50ml PP Oral Syrup Bottle

Polypropylene (PP):

Properties: Lightweight, flexible, and resistant to fatigue.

Benefits: Often used for smaller bottles or closures, polypropylene is resistant to many solvents and is safe for pharmaceutical use.

Considerations for Choosing Bottle Material

Compatibility: The material should not react with the syrup’s ingredients, preserving its effectiveness and taste.

Child Safety: Materials should be non-toxic and often feature child-resistant caps to enhance safety.

Storage Conditions: Some materials offer better protection against UV light, which can degrade certain medications.

Sustainability: As consumers become more eco-conscious, choosing recyclable materials can align with environmental goals.

The material of oral syrup bottles plays a vital role in medication delivery. Whether opting for PET, HDPE, glass, or polypropylene, understanding the properties and benefits of each can help ensure that the medication remains effective and safe for use. Always consult healthcare professionals or manufacturers for recommendations on the best packaging solutions for specific formulations.

Cryogenic Storage Vials-COP(Cyclo Olefin Polymer) vial

 In the world of medical research, biotechnology, and pharmaceuticals, storing biological samples at ultra-low temperatures is critical. Samples such as cells, tissues, proteins, or DNA must be preserved in a manner that maintains their viability and integrity for long-term use. Cryogenic storage vials are an essential tool in this preservation process, ensuring that samples remain frozen at temperatures as low as -196°C. Among the different materials available, COP (Cyclic Olefin Polymer) cryogenic storage vials are highly valued for their durability, purity, and compatibility with extremely low temperatures. We'll dive into the importance of cryogenic storage vials, particularly focusing on COP vials and their applications at -196°C.

Polymer Vial 2ml 5ml 10ml for cell and gene therapies

What Are Cryogenic Storage Vials?

Cryogenic storage vials are specialized containers designed to hold and protect biological samples during storage at ultra-low temperatures, commonly ranging from -80°C to -196°C. These temperatures are necessary for preserving sensitive biological materials without causing degradation, enzyme activity, or loss of cellular function.

Sterility and Compatibility

COP cryogenic vials are easily sterilized and are compatible with gamma irradiation, steam, and ethylene oxide sterilization. This makes them highly reliable for use in both clinical and research environments, where maintaining sterile conditions is paramount.

RTU(ready to use) 2ml COP vial

The Importance of -196°C: What Happens at This Temperature?

The temperature -196°C corresponds to the boiling point of liquid nitrogen, a common cryogen used in the storage of biological materials. At this temperature, cellular metabolism halts, preserving cells and tissues in a suspended state. Enzyme activity and other biological processes cease, preventing cellular damage that could occur at higher storage temperatures.

This extreme cold is critical for long-term storage, ensuring that samples remain viable for years. COP cryogenic storage vials are specifically designed to maintain their integrity under such conditions, preventing the vials from becoming brittle or compromising the stored samples.

Applications of COP Cryogenic Vials

Cryogenic storage vials are used across a wide range of industries and applications:

Biobanking: COP vials are widely used in biobanks, where human tissues, DNA, and other biological samples are stored for future research.

Pharmaceutical Research: Cryogenic vials play an important role in drug development, where biological samples need to be preserved over long periods for study.

Cell and Gene Therapy: Many therapies involve the use of preserved cells, and cryogenic vials are an essential component of these treatments.

Genomics and Proteomics: Researchers involved in sequencing DNA or studying proteins rely on cryogenic vials to maintain the stability of their samples at ultra-low temperatures.

Conclusion

Cryogenic storage vials made from cyclic olefin polymer (COP) offer a superior solution for storing biological samples at temperatures as low as -196°C. Whether you’re working in biobanking, pharmaceutical research, or cell therapy, COP cryogenic vials provide the reliability and protection necessary to safeguard your valuable samples.

Why COP Bottles Do Not Change Color After Irradiation Sterilization

 Irradiation sterilization is a critical step in pharmaceutical, medical, and food packaging industries to ensure that products are free from harmful microorganisms. While materials like glass and some plastics can change in appearance or degrade after exposure to radiation, Cyclo Olefin Polymer (COP) bottles remain remarkably stable. This stability makes COP an ideal material for sensitive applications. In this blog, we will explore why COP vials do not change color after irradiation sterilization and why they are preferred for sterile packaging solutions.

after Irradiation Sterilization

What is Irradiation Sterilization?

Irradiation sterilization uses ionizing radiation—such as gamma rays, electron beams, or X-rays—to kill bacteria, viruses, and fungi. This method is particularly effective because it penetrates deep into materials without the need for high temperatures, making it suitable for heat-sensitive products.

However, ionizing radiation can affect some materials by altering their molecular structure. For instance, certain plastics may discolor, become brittle, or lose mechanical strength. These changes can compromise product appearance and integrity, posing risks in applications that require high material performance and transparency.

What is COP?

Cyclo Olefin Polymer (COP) is a high-performance thermoplastic known for several desirable properties:

RTU(ready to use) 2ml COP vial

Optical clarity: Similar to glass, making it suitable for transparent containers.

High chemical resistance: Compatible with sensitive substances, including pharmaceuticals.

Dimensional stability: Resists deformation under varying temperatures and conditions.

Low extractables: Reduces the risk of contamination, making it ideal for medical and biological storage.

COP has become the material of choice for injectable drug containers, pre-filled syringes, diagnostic kits, and laboratory equipment, where sterility and product integrity are critical.

Why Do COP Vials Resist Color Change After Irradiation?

Stable Molecular Structure

COP is engineered with a highly stable carbon backbone. Unlike some polymers, it lacks certain chemical groups—such as aromatic rings or carbonyl groups—that are prone to reacting with radiation energy. As a result, irradiation does not trigger molecular breakdown or rearrangement that would cause discoloration.

100ml polymer vial

Resistance to Oxidation

Oxidation reactions are one of the main culprits behind color changes in irradiated materials. COP’s structure is resistant to oxidation, meaning fewer byproducts form that could affect color or transparency.

Minimal Crosslinking or Chain Scission

In many polymers, irradiation causes crosslinking (linking of molecular chains) or chain scission (breaking of chains), which can alter the material's appearance and performance. COP exhibits minimal crosslinking under radiation exposure, preserving its clarity and physical properties.

Low Additive Content

Some plastics contain additives, like dyes, stabilizers, or plasticizers, which may degrade under radiation and cause discoloration. COP typically has low or no additives, ensuring that it remains stable during sterilization.

Application of HDPE container with desiccant cap in dry syrup

In the pharmaceutical industry, dry syrup is a popular oral dosage form for children and elderly patients due to its high bioavailability and good drug stability. However, the effectiveness of dry syrup depends largely on its storage conditions, especially moisture-proof measures. This article will explore the important application of pharmaceutical HDPE desiccant bottles in the storage of dry syrup and its impact on drug stability.

50ml desiccant bottle with CRC

Characteristics and advantages of dry syrup

Dry syrup is usually in powder form and needs to be mixed with water before taking, which is convenient for patients to take. Compared with traditional tablets and capsules, dry syrup can disintegrate outside the mouth and quickly form a uniform suspension, thereby improving bioavailability. This makes dry syrup the preferred dosage form for many drugs, especially those for pediatric patients.

Storage Challenge: The Importance of Moisture-proof

The storage conditions of dry syrup directly affect its effectiveness. Due to the special nature of its ingredients, once affected by moisture, it may cause the drug to deteriorate, decompose or become ineffective. Therefore, moisture-proof measures are key to ensuring the stability and efficacy of dry syrup.

desiccant bottle with silica gel

Design and materials of pharmaceutical HDPE container with desiccant cap

Pharmaceutical moisture-proof bottles are usually made of polyethylene or polypropylene materials, which have good barrier properties and can effectively isolate external moisture and impurities to protect the drug ingredients in the bottle. In addition, the design of moisture-proof bottles usually takes into account sealing performance to ensure a dry internal environment.

To further enhance the moisture-proof effect, desiccants are generally placed in pharmaceutical moisture-proof bottles, and desiccants are usually placed on the top of the lid. These desiccants can effectively absorb the residual moisture in the bottle to ensure that the dry syrup remains stable throughout the storage period. By maintaining low humidity, desiccants help prevent physical and chemical deterioration of drugs, thereby ensuring that the efficacy is not affected.

Pharmaceutical moisture-proof bottles play a vital role in the application of dry syrups. By selecting the right materials and designs, and combining them with effective desiccants, these desiccant bottles provide a stable storage environment for dry syrups, ensuring the long-term effectiveness and safety of drugs.