Pharmaceutical Packaging, Different types and Benefits of pharmaceutical packaging

 The medical field has been playing an important role in everyone’s life not only in human life but also in the life of other living species. The most important part of the medical field is the “Medicine” and when it comes to medicine, the manufacturing process and the packaging play a very critical role.

So, what is pharmaceutical packaging, how it’s been done, does it have different types, what are the materials used? Well, let’s reach out to all such questions and more.

Whether it’s any other product or medicine, packaging plays an important part in all.  Packaging has often been referred to as the 5th P of the marketing mix. In the case of medicines, the packaging is not just part of the marketing mix but very critically related to the product features, application, and shelf life. The packaging of drugs is important to protect drugs from damage, germs, outer atmosphere, and bacteria and at the same time have to take care of child and old age safety concerns.

Types of Pharmaceutical Packaging:

1. Containers

2. Aluminium foil

3. Injectibles/ Vials

4. Bottles

5. Cartons

6. Paper Board

7. Lamitubes

8. Paper

9. PVC Based Combinations

Packaging in the pharmaceutical industry varies from drug to drug and normally there are three levels of packaging commonly referred to as the primary, secondary, and tertiary packaging.

1. Primary packaging system is the material that first envelops the product and holds it i.e., those package components and subcomponents that actually come in contact with the product, or those that may have a direct effect on the product shelf-life e.g., ampoules and vials, prefilled syringes, IV containers, blister packs, etc.

2. Secondary packaging system is outside the primary packaging and used to group primary packages together e.g., cartons, boxes, shipping containers, injection trays, etc.

3. Tertiary packaging system is used for bulk handling and shipping e.g., barrel, container, edge protectors, etc.

Some commonly used types of primary pharmaceutical packaging are Ampoules, Vials, Blister packs, Bottles, and Sachet packaging. let’s check out each of them in detail.

Ampoules Packaging:

The ampoule packs are mainly taken in use for the packaging of a small number of liquid drugs. These containers are small in size compared to the vials packaging and are mostly used to store single-dose medicines and are made up of glass or plastic materials.

Vials Packaging:

Vial containers are also made of glass and plastic materials but are comparatively larger in size than the ampoules containers. These containers are also used to store liquid, solid, or powder drugs but their capacity to store drugs is more compared to the ampoules containers.

Blister packs:

Blister packs are commonly used for the packaging of solid doses like tablets and capsules & Losenges. The packs are mainly made up of thermoformed plastics and manufactured with the lidding of aluminum foil or plastic that could be torn using hand. A state-of-the-art blister pack usually comprises a basic coat of aluminium or robust paper or plastic and a transparent plastic film through which the individual tablets can then be squeezed one by one.

This has proved cost-effective to produce and also less wasteful than other types of packaging, as it requires relatively little material.

Tablets are easy to remove and to dose, thus contributing to better patient satisfaction.

The transparent film makes it possible to identify a product quickly and to enhance its advertising impact at the POS.

Over the past 40 years, blister packs have been adopted globally by the pharmaceutical industry because of the flexibility in design and high productivity that the process delivers for the packaging of oral solids.

Blister packs act as perfect sealing agents for microbes and provide stable and reliable solutions for pills. Blister packaging material is getting more popular as it provides an aseptic solution

Dosing accuracy reduces all medication errors. Blister packs are gaining popularity owing to their “smart” features; one can track whether the pills are taken on time or not. Nowadays, blister packs are being linked with sensors that send alerts to smartphones, thereby reducing medication errors.

Bottles:

Pharma Pet Bottles

Pharmaceutical packaging bottles are usually available in two types of glass and plastic bottles. They are mostly available in orange and light brown color as these colors protect liquid drugs from ultraviolet lights.

Sachet Packaging:

Sachet packages are small pouch available in different shapes and sizes e.g: square and rectangle shapes. These pouches are mainly made up of a particular type of plastic, gives paper-pouch kind of look to the pouch and could be easily torn by the hand. These pouches are affordable and can only be used once, as once torn couldn’t be reused.

Benefits of Effective Pharmaceutical Packaging:

Nowadays, there has been huge competition in every field. so, the outer look and packaging of the product play an important role, the pharmaceutical packaging is not just about attracting or convincing people to purchase the medicine but a lot more. To keep the drug safe packaging plays a very important role but the most critical aspect is the material used for packaging as the drugs should remain safe during the course of its shelf life and should not react with the material of the containers.

The information and guidance mentioned over the packaging should be mentioned in detail, clear, and readable which would make packaging looking more effective and trustworthy.

The effective packaging of drugs is really important, making drug packaging better not only benefits the patients but also increases the trust of the consumer to the particular brand which would indirectly increase sales.

Corrosion on tablet tooling its effect and remedies

Tablet tooling: Don’t let it corroded

Corrosion can severely affect tablet compression tooling if it is not addressed effectively. It can delay production, reduce efficiency and cause contamination problems.

Corrosion can be detected by the appearance of discoloration, etching or common red rust. The main cause of corrosion is acidic substances, which can include ingredients found within the formulation being compressed and even in the surrounding atmosphere. The iron particles in the metal tooling are exposed to oxygen and moisture in the form of humidity or vapor. When the steel is exposed to water, the iron particles are lost to the water’s acidic electrolytes. This means they oxidize the iron particles, which form corrosion on the punches and dies.

There are several reasons why corrosion can occur, and although challenging, it can be resolved with a combination of the correct steel, coating or treatment selection and proper maintenance procedures.

Atmospheric moisture

One of the principal causes of corrosion is excessive moisture and humidity. This is because corrosion often forms in areas where the liquid is present. Oxygen is found in the air we breathe and humid air carries water. The percentage of water vapor in the air varies based on temperature and can range from as low as 0.2% to up to 4% water vapor.

Excess humidity in the compression room, tool storage area or places where the drug formulation is stored prior to compaction can have a significant impact on corrosion forming on the tooling. It is therefore extremely important to control the environment in all areas of tablet production.

As we cannot remove oxygen from the air and tooling is made from steel, environmental factors should be in place to regulate the temperature and humidity and minimize moisture to prevent corrosion from forming on the punches and dies.

Formulation content

All formulations have very different characteristics with varying moisture content, which is often needed to help bind the tablet structure. However, too much water within the tablet can be a cause of corrosion and lead to other problems like sticking.

It is not just moisture content within the formulation that can lead to corrosion. Formulations containing corrosive elements such as chlorine, salts and acids will react with the tooling surfaces and result in oxidation. In addition, wash-in-place systems fitted to some modern tablet presses expose tooling to water and cleaning solutions. Post-compression cleaning procedures can also cause corrosion if not controlled appropriately. It is therefore important that tooling has the appropriate corrosion-resistant properties through the correct steel and coating selection.

Protecting against moisture

Optimizing the environment in which tablet compression and storage of tooling takes place can have a significant impact on preventing corrosion, but other solutions, including tooling material, coatings and maintenance, should also be considered.

Tool steel selection

Wear and degradation of tooling are inevitable in tablet manufacture. The repetitive cyclic action of compression will take its toll on tooling, particularly if they are not maintained. A substantial influence on tooling deterioration is the formulation being compressed. Some products can cause adverse effects on the punch tips — for example, certain granules are extremely hard and abrasive. These can scratch, wear and impregnate the steel surface. Other granulates can contain corrosive elements which react with the steel. This deterioration can lead to tableting defects like black spots, which are the result of corroded tooling and sticking where the granulation adheres to the punch tip face causing costly wastage, reduced yield and unwanted press downtime.

Although tools are manufactured from hardened and tempered tool steel, the demanding processes involved can lead to deterioration if the tool material is not optimized to suit the formulation being compressed.

High-quality tooling should be able to offer long life and be anti-abrasive and wear-resistant. The appropriate choice of material will help to reduce the risk of damage to the punches and dies from the effects of abrasion, corrosion and impregnation of hard granules.

The correct steel is crucial to the successful performance of tablet compression tooling. There are several characteristics that should be addressed when selecting steel:

Strength: Ability to withstand an applied stress without failure

Corrosion resistance: Resistance to oxidizing, staining and discoloration

Toughness: Resistance to chipping, cracking and punch tip breakage

Abrasive wear resistance: Resistance to abrasive wear of punch tips and die bores

Adhesive wear resistance: Resistance to adhesive wear, galling and welding

Hardness: Resistance to impregnation from hard, sharp granules

Compressive strength: Resistance to die bore ringing and plastic deformation of punch tip edges

Fatigue resistance: Progressive and localized structural damage that occurs when a material is subject to cyclic loading

If the tooling being used is prone to corrosion due to environmental effects or because of the characteristics of the formulation, a specially selected tool steel is a good option. Specialized martensitic stainless steels with high chromium content should be used as they have a higher resistance to oxidization, staining and discoloration of the tablet tooling.

Coatings and treatments

Tool coating selection can have a fundamental impact on production. When used in conjunction with high-quality tooling steel, tool coatings are a great method of solving tablet production problems. They allow for better tableting efficiency and output by reducing the requirement for tools to be taken out of production for additional cleaning and maintenance work to remove problematic residue, which, if left untreated, may cause potential production issues, such as corrosion, sticking and picking.

Traditionally, electro-plated hard chromium was the most popular coating used within the tablet tooling industry, but it has many disadvantages. When hard chromium is applied to tooling, a certain amount of hydrogen penetrates the substrate, which can decrease the steel’s working load by up to 20%. To counter this effect, the plated tools undergo a baking process known as de-embrittlement that reduces but does not eliminate the unwanted characteristic. It is also subject to micro-cracks which can develop during the plating process when the internal stress exceeds the tensile strength of the chromium. These micro-cracks are problematic because they provide a porous route to the substrate that will allow granule or cleaning solutions to attack the steel beneath.

Specialized coatings have been developed which are chromium-rich and applied via an advanced Physical Vapor Deposition (PVD) process. The PVD process creates a very smooth dense anti-stick coating. This process incurs none of the drawbacks associated with applying hard chrome.

When it comes to choosing a tool coating, understanding the product being compressed is crucial. For example, if the formulation has a high number of corrosive elements like salts and acids, it will eventually react with the steel and result in oxidation and other forms of decay. In these instances, an appropriate corrosion-resistant coating should be selected, for example, those containing chromium or chromium nitride.

Tool maintenance

Incorrect tool maintenance procedures including the handling, cleaning, polishing and storage of punches and dies can have a huge impact on tablet production. All these processes will expose the tooling to materials and environments where there is a risk of oxidization. It is therefore important that tried and tested maintenance practices are in place to prolong tool life.

The purpose of regular tablet tooling maintenance is simple: to minimize compression problems and ensure that it operates at its highest functionality. Ensuring tablet punches and dies are kept in optimum condition to produce high-quality tablets is critical for productivity and overall equipment effectiveness (OEE). Frequent audits of procedures should be planned to maintain and protect against corrosion issues. The cost of poor tool care and maintenance not only results in additional unnecessary tool purchases but also in production problems that could have been avoided.tooling is cleaned without corrosion inhibitor or insufficiently dried, corrosion can take place.

The appropriate cleaning procedures are essential when looking to prevent corrosion. It will remove granules from the punch and help to avoid product contamination and potential production issues such as sticking and picking caused by old products adhering to the surface of the punch tip.

Post-cleaning is also the ideal time to accurately assess the condition of the tooling. If punches are not clean, any visual assessment of the punch tips and die bores can be affected. This would mean that problems like wear, damage or corrosion are missed.

When tooling is removed from the tablet press, it must be thoroughly cleaned to remove any oil or product residue, particularly from difficult-to-reach areas such as embossing and keyways. One of the most reliable cleaning methods is ultrasonic cleaning. Ultrasonic baths allow for consistent cleaning results, reduced processing and operator time, and reduced risk of tablet contamination. Importantly, ultrasonic cleaning allows for the whole punch to be cleaned including in and around the embossing. It is essential, however, that the process does not cause corrosion of the tooling material, therefore a corrosion inhibitor should be added to the cleaning cycle at a defined concentration. This will form an oxide film on the surface of the metal, passivating the steel and protecting it from corrosion.

It is also important to remember to thoroughly dry tooling after cleaning to ensure there is no residue of cleaning fluids left on the tooling surface which could cause corrosion.

Appropriate storage is another critical process to consider when preventing corrosion. Tooling can be exposed to moisture if the storage system is not clean and dry. A good storage facility with tooling protected by a layer of non-toxic, FDA compliant oil or grease will help prevent corrosion from forming on the tooling surface. The duration of the tooling storage will determine if oil (short term) or grease (long term) is required.

Handling of the tooling can be another cause for concern. It is always recommended to use gloves when picking up the tooling. This is because acids and moisture are present in human hands and can cause and accelerate corrosion on tooling. It is not unheard of for a rusty fingerprint to be left behind! Ensuring gloves are worn at all times and following proper maintenance procedures and techniques will prevent this from happening.

Adopting a simple structured tooling maintenance process is essential to obtain the maximum life from punches and dies. By applying these recommended best practices problems like corrosion will be prevented and tool life will be extended.

Keep a check on corrosion

The cost of corrosion due to not understanding the characteristics of the formulation and poor tool care and storage not only results in additional unnecessary tool purchases but also in production problems that could have been avoided. It is important to address corrosion at the root cause so tablet production is not affected.

Know the granule being compressed, does it contain hard and abrasive granules or ingredients that contain chlorine, salts and acids? Is there high moisture content in the air where compression and storage take place? If the answer is ‘yes,’ it is important to protect tooling so corrosion does not take hold.

Through the use of the correct tool steel and corrosion-resistant coatings, the durability and efficiency of tablet tooling will increase. Add to this effective maintenance and tool care procedures and pharmaceutical manufacturers can obtain the maximum life from tablet punches and dies.

What is Data integrity and ALCOA plus in pharmaceutical industry

 What is Data Integrity?

Data integrity is the maintenance of, and the assurance of, data accuracy and consistency over its entire life-cycle and is a critical aspect to the design, implementation, and usage of any system that stores, processes, or retrieves data.

Data integrity is a key approach in the pharmaceutical quality control system. ALCOA is (Attributable, Legible, Contemporaneous, Original, and Accurate) was introduced in the 1990s for ensuring the pharma industry as a framework for data integrity and Good documentation practice (GDP). Then further introduced ALCOA plus is (Complete, Consistent, Enduring and Available) Currently used by the FDA, WHO, PIC/S, and GAMP. So overtime periods, data integrity concepts expand from ALCOA to ALCOA plus for ensuring data security and integrity ( data protection) are observed and maintained.

ALCOA+

ALCOA has five basic principles (Attributable, Legible, Contemporaneous, Original, and Accurate) to stop data integrity issues.

Attributable:

The collected data must be attributed, who performs the action and when, if a record is changed, who did it and why? For example, when during conducting of validation, the test result must be dated, and the initial should be done by the person involved in conducting the test. If any change in the monitoring system, the change detail should be in the audit trail and any correction made by the person should be recorded and dated. A signature log must be for the identification of initials and the person who completed the paper record.

Legible:

Legible data means the data can be easily read. This attribute should be ensured both in the short and long term, therefore the materials used in recording and collecting the data should be durable.

Contemporaneous:

The data should be recorded at the time and date of work performed. The timestamp should we follow in order.

For example, when conducting validation protocol, the result of the test performed should be recorded in an online sequence. Recording the results should be dated with a timestamp then logged in the electronic system.

Original:

The information must be recorded as original or in a certified true or original copy; this may be an acceptable protocol or a database or a notebook.

For example validation test is being recorded on a given protocol because recording test results in a Notebook may be a chance of error. If the original data is handwritten, it must be stored in an electronic system.

Accurate

For data and records to be accurate, they should be free from errors, complete, truthful and reflective of the observation. Editing should not be performed without documenting and annotating the amendments.

For example:

• Use a witness check for critical record collection to confirm accuracy of data.
• Consider how to capture data electronically and verify its accuracy. Build accuracy checks into the design of the electronic system.
• Place controls/verification on manual data entry, for example, temperature results can only be entered within a predefined range of 0-100°C.

ALCOA PLUS (+)

Complete:- All data should be complete including, test repeat or re-analysis performed on the sample.

Consistent:-  Consistent in a generation of record and application of date and time stamps in the expected sequence.

Enduring:- Data should be recorded in a controlled worksheet in laboratory notebooks or invalidated Electronic systems.