How to Beat Hidden Costs in Clinical Packaging?

How to Save on Pharma Packaging?

It might be an understatement to say how incredibly valuable time is in today's business environment, but it needs to be emphasized until we all are more cognizant of opportunity costs. Since we could always use more time and opportunity to do what gets the best return, we can save both time and energy in these five key areas and get the product packaging you need for optimal function and shelf appeal.

Here are the savings we're seeking out for customers:

1. Sourcing the best packaging components or total solution from huge global network. Global networks like ours don't just spring up overnight, but Clinical packaging specialists have an extensive history of growing network for the long-term. Our customers don't have to start from scratch and each of our experiences lead to your gains.

2. Sharing industry knowledge to help customers stay on top of changes in regulations and more. Whether it is a required change for child resistant packaging for products containing imidazolines or a rather obscure best practice talked about deep inside the clinical  packaging    industry.

3. Finding the best freight option.  Make this as simple as a few questions for you and then run with it to get your product from where it starts to where it needs to arrive at the time it's needed. Always looking to save you time and deliver superior customer service, and this is a prime example of one area we do everything to deliver on that.

4. Holding network to a high set of standards to deliver the highest quality products. Global advantage is something we take much pride in, so we utilize every opportunity to bring a world-class approach. 

5. Utilizing knowledge that comes from year after years of experience as a leader in the packaging industry. At Bilcare Packaging, work is a tradition handed down through the family and to extended family of employees building long-term relationships and packaging authority. Teams of experts and specialists have always worked for the long-term and lead so customers can have every advantage possible.

Clinical Packaging Firms

Clinical packaging is a vital component of the medicine delivery system as pharmaceutical companies have to be extremely careful that their drugs reach the end user in a sterile and usable condition. The packaging has to meet stringent FDA standards, be suitable for the contents and also be easy to transport and keep on shelves, be antiseptic, tamper proof, have childproof caps at the same time being senior friendly. When  medicines have to be used in a hospital or institutional environment, they may require different packaging than when they are used by a retail customer. Medicine packaging is used by pharmaceutical companies

Pharmaceutical companies manufacture a wide range of medicine with different delivery systems including:

· Ingestible liquids

· Sprays

· Drops

· Creams, ointments and gels

· Tablets

· Gel caps

· Dispensers

Often specific medicine need very special packaging – sometimes doses have to be marked, sometimes medicines have to be available in a single dose, disposable container. Other times drugs have to be dispensed in particular quantities in containers that are safe for long-term use.

Clinical packaging has to be done in impermeable containers that are strong enough to keep the contents safe during handling and transport. The product should be safe from adulteration, biological contamination or physical damage. Containers may be available in:

· Glass

· PVC

· PET

· Polycarbonate

· Polypropylene

· LDPE

· HDPE

· Polystyrene

With advances in technology and packaging materials, you can get the right packaging for your drugs that are safe, meets all the regulatory standards and is attractive.

If you need the proper packaging for your pharmaceutical products, you have come to the right place. Bilcare can easily source what you need and even suggest the correct packaging solutions for your medicine. You can design special packaging containers for your products as well and our design team is always ready to help you. What's more, we offer the best rates and friendly services – once you come to us, you will never go anywhere else.

Bilcare Research expands its pre-clinical and early-stage development capabilities of clinical packaging

In its endeavor to accelerate the development process cycle resulting in enhanced “Speed to Market” for its clients, Bilcare Global Clinical Supplies, a leading single-source provider of Clinical Packaging, Clinical Trial Supplies and services, endorses its continual capability enhancement commitment by supplementing its ability of developing functionally viable and innovative formulation dosage forms for pre-clinical and early-phase drugs.

Vincent Santa Maria, President – Bilcare, Americas stated that as part of a major capital investment program at its facilities in the U.S., Bilcare Research has added sophisticated fluid bed granulation and enhanced capsule filling technologies to its R&D Center. “With this upgrade, Bilcare Research can now quickly produce a wider variety of drug dosage forms with high product quality at par industry benchmark. These investments in R&D services further prove our commitment to being a full-service partner to our global customers with the offering of a wide breath of specialty services like clinical packaging, continues Vincent.”

This capability enhancement compliments the increasing number of investigational new drug (IND) applications by innovator pharma and Biotech companies, which in turn requires multi-pronged expertise, more particularly in the Formulation and Analytical research and development, commented Praful Naik, Ph.D., Chief Scientific Officer, Bilcare Limited.

The fluid-bed granulation technology extends Bilcare’s solid dosage formulation capabilities. The granulation system equipped with Wurster coating inserts enables Bilcare to develop and deliver specialized coating processes for granules and non-pareils with high precision and consistency for creation of top quality sustained and controlled-release tablet and capsule formulations.

The In-Cap® capsule system, capable of filling several thousand capsules per hour in multiple permutations, is a versatile tool for pre-clinical and early-stage development. This equipment extends both development and clinical manufacturing capabilities for a myriad of formulation types including powders, pellets, tablets and liquids.

“Bilcare’s R&D center can now develop a broad array of dosage forms with innovative delivery mechanisms, which exceeds those developed by pharmaceutical companies,” says Frank Santillo, Ph.D., Bilcare Research’ senior director for research services. “Most importantly, we have the expertise to take a drug candidate from concept to clinical production without the client suffering critical and costly delays as a result of hand-offs, continues Frank”

About Bilcare Global Clinical Supplies

Bilcare Global Clinical Supplies serves the Americas, Europe, and Asia with clinical trial materials support, services, and complete project management. Its services for solid, semi-solid, liquid, DEA (CI-V), and biotech clinical trial materials (CTM) satisfy a broad range of requirements; from pre-formulation research and development, manufacturing, analytical services and clinical supplies clinical packaging and labeling, to IVRS, QP services, controlled temperature (cold chain) CTM storage, worldwide distribution, and returns and destructions accountability.

Bilcare focusing on unique clinical packaging techniques

Counterfeiting of items and goods is a problem for many of us as it put our lives at risk and give a free pass to those opportunity seekers who initiate such things for their own financial benefit. Pharmaceutical industry is coming up with numerous techniques and methods to cope with such problems and contribute in the well being of people.

Bilcare is a research and packaging based service provider which is excelling in pharmaceutical industry since its establishment in 1987. Bilcare is involved in implementing numerous packaging techniques, keeping in mind the individuals’ requirements. Be it thickness packaging or child resistant, environment friendly or easy for senior citizen to use, Bilcare has solution for every needs. They are the foremost company in pharmaceutical industry regarding their clinical packaging. Keeping in mind the recent trends and demand in market, Bilcare have a dedicated team of Research experts and specialists whose main concern is to ensure the health of their end customers along with their own brand recognition.

Their current technologies and methodologies which they use in their clinical packaging involve:

• nonclonableID
• BilcareOptima
• BilcareBrandpack

These technologies are the state-of-the-art techniques which are used exclusively by Bilcare as they are discovered by their R&D experts.. Their foiling and filming processes are also one of a kind which is not like any normal foiling or filming. Their all packaging films solutions are free of cadmium, phthalates and lead stabilizers, which helps in maintain the quality standards of the end product. Bilcare is renowned globally for its continuous efforts for providing the innovative clinical packaging solutions to end customers which avoid counterfeiting.

Competitive advantages of clinical packaging

Contract clinical packaging providers say they are well positioned to sourcing the necessary medical components and delivering them in a suitable pack for end users. They represent a valuable resource for clients to outsource traditional in-house activities, or companies who have a limited packaging and distribution infrastructure. All claim to provide effectively the same global services.

For example, Almac claims its IRT solution positions it as the top global player in clinical supply chain management. Rondo-Pak reports having an experienced and professional design team to assist clients in the critical secondary packaging selection process. “We work closely with the client’s process engineers to ensure the packaging will run efficiently on their designated filling equipment,” Bani says. “In addition, we can offer traditional printed packaging components as well as fully assembled cartons for ease of use and (the) speed to market aspects of the trial process.”

PCI offers “seamless support” from clinical to commercial. “Our ability to support clients in taking a compound from clinical development to commercial launch within the same organization and on a global platform provides substantial value to our clients,” Misher says. “We add value by bringing commercial considerations, insight and expertise much earlier in the development process, while at the same time providing a single provider and continuity of services for bringing drug candidates to successful commercialization.”

Sharp reports it is positioned to provide all of the key services that comprise the clinical supply chain. “By fully integrating these services, we are able to satisfy a wide range of customers who are looking to consolidate vendors,” Morris says. “We are also more able to effectively reduce inherent risks in clinical timelines by reducing the interactions which can be created by a complex network of service providers.” These services include, among others, comparator sourcing, clinical label design/printing, package design, clinical packaging, global storage and distribution.

Bilcare talks about the basic functions of packaging

Packaging is a domain where pharmaceutical companies cannot afford to care less. A minor negligence can wreak havoc to the medicines. This is one prime reason why Bilcare conducts extensive research when it comes to packaging. Packaging performs a few functions that are paramount for the safety and stability of the drugs and medicines. Bilcare highlights a few important functions of packaging:

1. Containment of medicines: This is the most important function of packaging. The design of packaging must incorporate the needs of the product accordingly. The packaging and containment must ensure that the medicine doesn’t leak and the material used for packaging does not affect or permeate in to the product. The packaging must also be strong enough to contain the medicines when handled a little roughly. This needs the packaging to be robust. The packaging must also not be affected by the content of the medicines. They should be non reactive to each other.

2. Offering Protection: The packaging must ensure that the product stays unaffected and potent even if exposed to influences like light, moisture, oxygen and mechanical damages.

3. Stability: It is extremely important to ensure that the content stays safe and does not react with the packaging material. Bilcare conducts various tests to make sure that the primary packaging material and medicines are inert towards each other.

4. Storage: Packaging materials have to be designed depending upon the storage of the medicine stored in them. For example, if there is a medicine that needs to be stored within temperature range of 2-6 degree Celsius, it is important to design a packaging material that can sustain such temperature conditions.

Bilcare explains the general aspects of clinical packaging

Packaging is an intrinsic part of the pharmaceutical industry. One might argue that the life and effect of a medicine largely depends upon the packaging and this would be extremely hard to counter. This is because the way a medicine has been packed impacts the robustness of the product when being transported across miles. Packaging involves storing the medicines and drugs in bottles, vials, strips and using components like closure, cap, ampoule etc. There are a few important aspects regarding the process of packaging which Bilcare Limited lays emphasis on during clinical packaging:

• Selection of a material suitable for packaging
• Rigorous testing of the selected material
• Filling the containers and assembling
• Sterilization for safety
• Storage and stability

Packaging materials used by Bilcare or, as a matter of fact, by any other pharmaceutical company include printed material used for packaging a product. This however does not include any outer material that is used in the transportation of the product. The important thing is to differentiate between the primary and the secondary packaging materials. 

• Primary:  are in direct physical contact with the product.
• Secondary:  are not in direct contact with the medicinal content. eg:  caps, cardboard boxes etc

Containers could pertain to the category of primary or secondary, categorized by the usage. Containers could be well-closed, tightly closed, hermetically closed or light-resistant.

The packaging process consists of the following stages:

• Filling and assembling
• Sterilization in the final container
• Placing labels on the container
• Storage at the manufacturing and shipping sites. 

Types of containers used for clinical packaging

Ampoule 

A container sealed by fusion and to be opened exclusively by breaking. The contents are intended for use on one occasion only. 

Bag 

A container consisting of surfaces, whether or not with a flat bottom, made of flexible material, closed at the bottom and at the sides by sealing; the top may be closed by fusion of the material, depending on the intended use. 

Blister 

A multi-dose container consisting of two layers, of which one is shaped to contain the individual doses. Strips are excluded. bottle A container with a more or less pronounced neck and usually a flat bottom. 

Cartridge 

A container, usually cylindrical, suitable for liquid or solid pharmaceutical dosage forms; generally for use in a specially designed apparatus (e.g. a prefilled syringe). 

Gas cylinder 

A container, usually cylindrical, suitable for compressed, liquefied or dissolved gas, fitted with a device to regulate the spontaneous outflow of gas at atmospheric pressure and room temperature. 

Injection needle 

A hollow needle with a locking device intended for the administration of liquid pharmaceutical dosage forms. 

Injection syringe 

A cylindrical device with a cannula-like nozzle, with or without a fixed needle and a movable piston, used for the administration, usually parenteral, of an accurately measured quantity of a liquid pharmaceutical form. The syringe may be prefilled, and can be for single-dose or multi-dose use. 

Pressurized container 

A container suitable for compressed, liquefied or dissolved gas fitted with a device that, after its actuation, produces a controlled spontaneous release of the contents at atmospheric pressure and room temperature. 

Single-dose container 

A container for single doses of solid, semi-solid or liquid preparations. 

Strip 

A multi-dose container consisting of two layers, usually provided with perforations, suitable for containing single doses of solid or semi-solid preparations. Blisters are excluded. 

Tube 

A container for multi-dose semi-solid pharmaceutical forms consisting of collapsible material; the contents are released via a nozzle by squeezing the package. 

Vial 

A small container for parenteral medicinal products, with a stopper and overseal; the contents are removed after piercing the stopper. Both single-dose and multi-dose types exist.

Clinical Packaging and Labeling at Bilcare Research

Bilcare has emerged as a best and well known pioneer company in terms of Clinical packaging and labeling. Bilcare GCS has proven to be an able ally in delivering end-to-end services for your global clinical supply needs.

With a world class facility and classified suits of ISO 7 and ISO 8 equipped with sensors to monitor temperature and humidity with appropriate pressure differential, dedicated AHU'S to facilitate different products packaging at the same time, the AHU system being controlled by Building Management System.

To maintain the confidentiality, the entry is restricted by means of access control majors.

Walk in cold rooms for packaging of cold chain IP'S with backup of UPS and three generators .These walking Cold rooms are equipped with Eurotherm's 21 CFR compliant data loggers with audio video alarms for temperature excursions. Apart from this, it has also got the facility of mobile and email alerts.

The packaging activity is controlled by a approved batch clinical packaging document which in turn is managed by SAP system to have a better control on inventory and expiration dates.

Persons working in the operations areas are minimum graduate.

The entire facility is equipped with smoke detectors, fire extinguishers and fire hydrants. Dedicated specially designed document archival.

Our unique approach enables us to support customer requirements for short-term studies as well as large-volume ongoing projects. This is irrespective of whether the requirement is from Phase I studies, that requires limited supplies or Phase III, requiring an almost bulk approach to packaging.

Strategies of Clinical Packaging and an unexplored industry in India

With the advancement of science and technology, we see new medicines and pharmaceutical products being offered by a number of companies & trustworthy organizations and the packaging of medicine is one of the key factors which are as important as the health of people consuming it. Humidity of environment where these drugs are being packed, retaining its stability, recycling regulations, minimization of wastage and other similar factors are considered while packing the medicines and drugs.

The new and on-going trends in clinical packaging are safe and reliable, and they are crucially designed by keeping the potential and sensitive drugs in mind. The trends are:

    
> Child-resistant and senior-friendly packaging: the drugs are packed in a way which is easier for senior citizens to deal with and consume; and equally complex for children to avoid its misuse.

        
> Contract packagers’ automation: Clinical packaging processes have become more complex with the implementation of serialization and introduction of stringent anti counterfeiting guidelines. Pharma companies are increasing automating packaging lines as a result of same.

         
> Eco-friendly packaging: number of drug manufacturers and clinical packaging companies are considering environmental issues while packing their product as environmental concerns are valid too.

>  Anti counterfeiting packaging: DGFT of India has made it mandatory to use bar codes and unique numbers on primary-secondary packaging, along with territory packaging which is easy for tracking and tracing serialization of exported drugs.

> Talking packaging: is an impressive method of attracting consumers as it is a digital kind of packaging which includes HD screen on the outer packaging of the consignment, but it involves huge maintenance and distribution cost and that is why it is not trending in India along with the newness of this idea and risk factors associated with it.

Progress of this industry is innovation driven which is need of this hour and it will keep on coming with fresh ideas for clinical packaging time to time.

OPTIMUM CLINICAL PACKAGING AT BILCARE

Clinical packaging is a big concern for pharmaceutical companies in today's time. According to ICH guidelines the optimal amount of humidity and temperature has to be maintained while packaging, so that the formulation retains its stability. Not knowing what the exact packaging requirement for their products is, the pharma manufacturers often end up either packaging their product above or below the desired requirement. Above requirement means they purposely pack their formulation in high barrier packaging materials. This is done to reduce analytical workload and qualifying for the stability tests. However, over-packaging may unnecessarily add up to the packaging cost.

Packaging below the desired requirements means that the manufacturer is focusing only upon the ICH guidelines. However, the ICH guidelines are formulated by considering the temperature and humidity conditions in Zone I & II (USA and European regions) only. These guidelines do not necessarily assure stability of a formulation in tropical regions. If a manufacturer decides to stick to ICH guidelines only, then it may lead to catastrophic losses for him in tropical regions. Bilcare has come up with a very innovative and cost-effective solution for this problem. Bilcare Optima is a result of 11 years of incessant study and analysis of exact packaging requirements of a formulation.

This first and only scientific packaging development method understands the exact packaging requirement of the pharmaceutical formulations. This is done through a scientific study that quantifies the environmental and dimensional sensitivity of the pharmaceutical formulations. Thus, it identifies the optimum packaging of any pharmaceutical dosage by understanding the degradation pattern of the formulation and then correlating it to the barrier property of the packaging material without conducting the conventional stability studies. Bilcare then submits the report along with recommendations for primary blister packaging materials and a suitable back up packaging alternative for the product within 30 days time after initiating the study.

Bilcare Optima works on the following principles:

# Sensitive profiling of solid dosage formulations.

# Scientific identification of optimum packaging.

Clinical Packaging: an innovation driven industry and its Strategies

Don’t judge a book by its cover but definitely judge a medicine and drug by its packaging, because better the quality, better the function of service which is promised. With the advancement of science and technology, we see new medicines and pharmaceutical products being offered by a number of companies & trustworthy organizations and the packaging of medicine is one of the key factors which are as important as the health of people consuming it.

There are lot of factors considered while doing the clinicalpackaging of medicines and drugs, like humidity of environment where they are being packed, retaining its stability, recycling regulations, minimization of wastage, etc. Clinical labeling not only provide the essential information to its user, but it also assures that the medicine-drug belong to the company which uses clinical trial material and clinical trial services for quality maintenance of its products.

The new and on-going trends in clinical packaging are safe and reliable, and they are crucially designed by keeping the potential and sensitive drugs in mind. The trends are:

• Child-resistant and senior-friendly packaging: the drugs are packed in a way which is easier for senior citizens to deal with and consume; and equally complex for children to avoid its misuse.
• Contract packagers’ automation: Clinical packaging processes have become more complex with the implementation of serialization and introduction of stringent anticounterfeiting guidelines. Pharma companies are increasing automating packaging lines as a result of same.
• Eco-friendly packaging: number of drug manufacturers and clinical packaging companies are considering environmental issues while packing their product as environmental concerns are valid too.
• Anticounterfeiting packaging: DGFT of India has made it mandatory to use bar codes and unique numbers on primary-secondary packaging, along with territory packaging which is easy for tracking and tracing serialization of exported drugs.

Talking packaging is an impressive method of attracting consumers as it is a digital kind of packaging which includes HD screen on the outer packaging of the consignment, but it involves huge maintenance and distribution cost and that is why it is not trending in India along with the newness of this idea and risk factors associated with it. Progress of this industry is innovation driven which is need of this hour and it will keep on coming with fresh ideas for clinical packaging time to time.

Clinical Packaging at Bilcare Research

Through comprehensive packaging research, Bilcare GCS produces customized and innovative clinical packaging materials. Bilcare GCS assists its clients in selecting appropriate packaging solutions through complete production and delivery.

Our packaging services are carried out by experienced clinical packaging professionals at our dedicated GMP compliant clinical packaging facilities:

# Bottling (solids / semi-solids)

# Blister packaging – any configuration

# Cold form & thermoform

# Blister card sealing and walleting

# Pouching / powder filling

# Label application and kit assembly

# Controlled substance packaging (schedule I – V)

# Ambient & controlled temperature (refrigerated / frozen) packaging

# Tube filling

# Creams

# Ointments

# Label printing with vision system.(Single panel,Multipanel booklet labels)

Bilcare GCS' extensive clinical services experience and expertise actively supports and helps customers in the decision-making process to understand the long-term impact of packaging decisions.

Clinical Packaging and Machinery used

A choice of packaging machinery includes: technical capabilities, labor requirements, worker safety,maintainability, serviceability, reliability, ability to integrate into the packaging line, capital cost, floorspace, flexibility (change-over, materials, etc.), energy usage, quality of outgoing packages, qualifications (for food, pharmaceuticals, etc.), throughput, efficiency, productivity, ergonomics, return on investment, etc.

Packaging machinery can be:

1. purchased as standard, off-the-shelf
2. purchased custom-made or custom-tailored to specific operations
3. manufactured or modified by in-house engineers and maintenance staff

Efforts at packaging line automation increasingly use programmable logic controllers and robotics.

Packaging machines may be of the following general types:

• Accumulating and Collating Machines
• Blister packs, skin packs and Vacuum Packaging Machines
• Bottle caps equipment, Over-Capping, Lidding, Closing, Seaming and Sealing Machines
• Box, Case and Tray Forming, Packing, Unpacking, Closing and Sealing Machines
• Cartoning machines
• Cleaning, Sterilizing, Cooling and Drying Machines
• Coding, Printing, Marking, Stamping, and Imprinting Machines
• Converting Machines
• Conveyor belts, Accumulating and Related Machines
• Feeding, Orienting, Placing and Related Machines
• Filling Machines: Handling dry, powdered, solid, liquid, gas, or viscous products
• Inspecting: visual, sound, metal detecting, etc.
• Label dispenser
• Orienting, Unscrambling Machines
• Package Filling and Closing Machines
• Palletizing, Depalletizing, Unit load assembly
• Product Identification: labeling, marking, etc.
• Sealing Machines: Heat sealer
• Slitting Machines:
• Weighing Machines: Check weigher, multihead weigher
• Wrapping machines: Stretch wrapping, Shrink wrap, Banding
• Form, Fill and Seal Machines
• Other specialty machinery: slitters, perforating, laser cutters, parts attachment, etc.