Bilcare points out the best ways to develop an RFP

Request for proposals (RPF) is usually put up by a pharmaceutical company having a drug product looking for a contract manufacturing site.  RPF includes all the information about the organization and time & cost involved. It is a crucial aspect that has a major effect on the relationship between the manufacturer and sponsor. The transfer of technology and the cost of commercial products can be adversely affected by a poorly organized RPF. It also has the potential to slow down the process of selecting the best manufacturer. Bilcare, a prominent name in the medicine packaging industry points out the important aspects an organization should ensure while developing a RPF. 

A well organized RPF should cover all the information like the manufacturing process involved, the formula used, the use of specialized equipment, raw material and packaging components used, analytical specification & methods, the API safety data and the materials & associated grades or specifications needed. The other details include the size of the bottle and cap, the use of desiccant, the quality control testing required and the regulatory strategy. 

All the outsourced activities are controlled and reviewed under the ICH Q10 guidelines. The FDA and ICH requires a technology transfer to achieve product realization through the smooth transfer of comprehensive knowledge of the process and product. Bilcare points out that communication is a crucial part of this process. It is recommended by the FDA as it acts like a quality agreement for stating the responsibilities and roles of each party.  

The company focuses on the need for ensuring environment friendly and safety measures in the process of formulization. Bilcare states that these measures can be ensured through a material safety data sheet (MSDS) and Safe Bridge Consultants Potent Compounds Safety Rating, which safeguards the manufacturing employees from all potential risks involve

Medicine Packaging Firms

Medicine 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.

Medicine 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.

Types of Medical Packaging Missteps to Avoid

Medical device packaging engineers often face tight deadlines and budgets. So when the members of the Flexible Packaging were brainstorming recently on how to help package engineers, the group decided to focus on how they could help packaging engineers minimize cycle times, iterations, and costs during new package development.

Misstep 1: Missing Some Stakeholders

One of the first missteps discussed in Medicine Packaging is not taking into account stakeholders “There’s a growing emphasis on eliminating all defects in the packaging process, so the challenge is designing a defect-free package that accommodates all Critical to Quality (CTQ) [attributes] while meeting design constraints such as cost and manufacturing,” he said. “Avoiding missteps starts with making sure you include all your stakeholders in the design process. Stakeholders are both internal and external, and they all have their own CTQs that need to be considered.”

One example involves package dimensional tolerances. “We often see specifications that call out dimensional tolerances that may or may not be realistic. “Make sure the specification you are calling out is something that your supplier can actually manufacture. It is an example of including your external stakeholder early in the design process.” Other mistakes involve neglecting critical dimensions.

Misstep 2: Mismeasurements in Heat Sealing

 Mistakes in Medicine Packaging can also be made during heat-sealing processes. There are several misconceptions when it comes to parameter measurements and machine set up. One is assuming “that setting and actual sealing conditions are the same,” he said. For instance, there can be differences between the temperatures of the gauge versus the actual temperature of the platen surface, he said. Also, there can be differences in dwell-time measurements depending upon when the sealer activates the timer—is it when the platen begins to move or when it is closed and pressure begins?

Misstep 3: Misunderstanding Distribution's Effects

 And missteps can also occur when distribution’s influence on package performance isn’t considered. One common misstep is to use a pouch that’s too large for a folding carton, explained Russell Darley, R&D Manager for Sealed Air Medical Applications. “To fit the pouch in the carton, the pouch must be folded several times; we call this creating a compound fold,” he said. “Multiple folds in a material can create material stress points, which during distribution events like vibration, impact, or free-fall drops can result in abrasion, flex cracking, pin holes, and material separation.” Using pouches and cartons that aren’t appropriately matched can be the outcome of programs that use a one-size-fits-all approach to packaging.

As a result, they might not select the appropriate distribution simulation protocol and could see damage in the field, a poor product-to-packaging ratio, or experience other missteps. He offered a few key recommendations on how to better understand such channels. “Spend time out in the field following your distribution channel, map the process, talk to employees, and make observations.