WHAT IS EPOXY AND ITS BENEFITS

WHAT IS EPOXY AND ITS BENEFITS

The floor coatings of companies manufacturing medicinal drugs should manage to resist most oils, acids, and solvents. Also, the coating must be resistant to abrasion and impact since the plant’s floors could easily be exposed to heavy traffic from hefty tools and machinery. A type of floor coating that can surely offer durable and hard wearing solutions is the epoxy flooring. This type of floor coating can be applied over concrete floors to ensure a high performance as well as an attractive surface.

Epoxy consists of epoxy resins and hardening agents. These may sound like a bunch of scientific jargon thrown together but it is the secret behind industrial grade durability of the floor. Epoxy resins also called polyepoxides are a polymer (a large molecule made of repeating small units) made of epoxide monomers. These resins can be crosslinked either with themselves or other agents such as phenols, acid anhydride, etc through a process called curing. These other substances are called hardening agents or curative. Epoxy flooring is basically deposition of a coating of epoxy on the floor at least 2 millimeters thick. The result obtained is so strong and durable that it finds industrial application, especially in pharmaceuticals.

It is required to have a hard wearing, high gloss, and durable surface for your pharmaceutical structure, Epoxy flooring offers a wide range of benefits from installation to maintenance.

Here are more details about epoxy flooring and its benefits in pharmaceuticals:

1. Brings forth an easy-to-clean surface:

Floor areas with epoxy floor coatings can easily be wiped free of dust, dirt, and debris. Pharmaceutical preparations can create a great deal of mess, and epoxy flooring is the way to go.

2. Results in a highly durable surface:

Epoxy is a thermosetting resin which forms tightly linked cross-polymer structures. This makes it uphold its toughness and strong adhesion. When used as floor coatings, any floor surface can stand the test of time.

3. Provides an aesthetically pleasing flooring surface:

When the epoxy floor coatings dry, a high gloss surface shines which could come in various colors and styles. There are a lot of color and design options available that will suit your liking and the theme of your building.

4. Becomes a chemical- resistant surface:

Epoxy is composed of hardeners and resins. Once combined, these components chemically bond and lead to a chemical reaction that forms a rigid and strong plastic material which is chemically resistant. This feature is perfect for warehouses, manufacturing plants, and industrial plants.

5. Improves safety:

Epoxy floorings provide solutions that are the impact, slip, heat, and fire resistant. The brightness of the whole working space can also be boosted by 300% because of this high gloss floor coating.

6. Allow for designated work and traffic zones:

Because of its wide color options, you can use different colors to indicate forklift traffic zones, safety zones, and other pharmaceutical work zones.

7. Increases productivity capacities:

When epoxy flooring is used in a warehouse, factory, or industrial plant, the wear on the transport vehicles can be reduced. Also, the material movement can be made faster without causing damage to the floor. This eliminates the usual unnecessary problems in the workspace.

8. Allows for fast and easy application:

The installation is super easy for professionals as it’s a self-leveling product. You can save a great deal of productive work time here.

9. Offers a cost-efficient flooring solution:

Most flooring options that are not as durable as epoxy tend to easily wear and tear. However, with epoxy floor coatings, you no longer have to keep up with the maintenance costs.

Tiny crevices in the usual flooring tend to have small pockets of the favorable environment for bacteria and other microorganisms to grow. Bacterial growth is further supported by the relative difficulty in cleaning these areas. This limitation of conventional flooring is eliminated with the seamless and crevice free option of epoxy flooring. Therefore, not only is this easy to clean and maintain but also helps to maintain a sterile environment.

WHAT IS BMR ( BATCH MANUFACTURING RECORD )?

WHAT IS BMR ( BATCH MANUFACTURING RECORD )?

Batch manufacturing record is a written document of the batch that is prepared during the pharmaceutical manufacturing process. It contains actual data of the batch manufacturing and whole manufacturing process step by step.

There are several stages of the pharmaceutical tablet manufacturing process. All stages are included in the batch manufacturing record from issuance of the raw material to the final packaging. Every batch has a separate BMR having the batch history of batch production. Documents and the proofs are attached in the BMR during the manufacturing process.

A good Batch Manufacturing Record format should contain following parts:

1. Batch Record: Very first page of the BMR has all records about the batch as batch number, batch size, composition, master formula record referred, weight of the batch, shelf life, storage conditions, manufacturing license number, manufacturing date, expiry date, date of starting and date of completion.

2. General Instruction for Manufacturing: Health and safety instructions to the operators and the manufacturing chemist are written those should be followed during the manufacturing process regarding the material and equipments used during manufacturing.

3. Equipment Cleaning Record: Checklist of the cleaning of all equipments is prepared; those are used in the manufacturing of the batch including the previous product, batch and date of cleaning. Cleaning of the equipments should be checked by the quality assurance.

4. Bill of Materials: List of the raw material should have the quantity of the materials with their AR numbers. Weights of the materials should be verified by quality assurance. If tablets are coated then coating material should be included.

5. Manufacturing Process: Manufacturing process should be written step by step in easy language. Milling, sifting, drying, lubrication, compression, coating and packing having all instruction with process time should be written. Checklist for line clearance should also be attached before starting every process.

After completion of the every stage, tablets must be checked for the compliance of the specification of that stage. Results should be attached with the batch manufacturing record.

6. Yield: Yield of the batch should be calculated at the end of every stage to calculate the process loss. Final yield should be calculated at the end of the manufacturing that should not be less than 99.00%.

7. Abbreviations: List of the abbreviations used in the document should be made to understand the BMR easily.

8. History of Chances: At the end, the document should have a list of the changes in the document including the revision number and the date of the change.

TABLET AND TYPES OF TABLETS

What is tablet?

Tablet is a solid dosage form in which powder, crystalline or granular form of drug is compressed in a disk or molded. It is the most frequently used means of administering a drug. Most of the tablet is administered orally. However, the tablet for application as implant, solution, vaginal use, and external use are also available.

TABLETS

Oral tablet is designed to release the drug within the gastrointestinal tract for absorption into the circulation or more rarely for a local effect. It is usually swallowed or dissolved in water before taking.

The molded tablet is softer than the compressed tablet. The molded tablet dissolves rapidly when administered by placing under the tongue. The compressed tablet offers many advantages to the patient, the prescriber and the manufacturer. There may be single or multiple compressed drug following oral administration.

To make the tablet well acceptable to the patient and easier to swallow, the tablet is prepared in different shapes and sizes. The tablet is usually discoid in shape. It may be available in other shapes such as round; oval, triangular or elliptical .The upper and lower surfaces of a tablet may be flat or convex. The tablet may be marked with a line across the surface so that it can be broken into halves easily. Sometimes the tablet may be marked with trade name with or without the amount of the active ingredient.

Types of tablet:

Chewable tablet-The tablet which is intended to be broken and chewed in between the teeth before ingestion. Antacid and vitamin tablets are usually prepared as chewable tablets. It is given to the children who have difficulty in swallowing and to the adults who dislike swallowing.

Effervescent tablet-The tablet that contains acid substances and carbonate or hydrogen carbonate that react rapidly in the presence of water to release carbon dioxide. Sodium bicarbonate, citric acid and tartaric acid are added to the active ingredients to make the tablet effervescent. This preparation makes the tablet palatable.

Lozenge tablet-The tablet that is intended to produce continuous effect on the mucous membrane of the throat. There is no disintegrating agent. The quality of the binding agent is increased so as to produce slow dissolution. Suitable sweetening (sugar), coloring and flavoring agents must be include in this formulation. Gum is used to give strength and cohesiveness to the lozenge and facilitating slow release of the active ingredient.

Soluble tablet-The tablet that dissolves completely in liquid to produce solution of definite concentration. Mouth wash, gargle, skin lotion, douche; antibiotic, certain vitamins, and aspirin are given in this formulation.

Sublingual tablet-The drug which is destroyed or inactivated within the gastrointestinal tract but can be absorbed through the mucosal tissue of the oral cavity is usually given in this formulation. The tablet is required to be placed below the tongue for the slow release of drug. But for immediate effect some medicaments are formulated in such a way to dissolve within 1 to 2 minutes. Nitroglycerin is prepared in this formulation.

Enteric coated tablet-Some drugs are destroyed by gastric juice or causes irritation to the stomach. These two factors can be overcome by coating the tablet with cellulose acetate phthalate. This polymer is insoluble in gastric contents but readily dissolves in intestinal contents. So there is delay in the disintegration of dosage form until it reaches the small intestine. Like coated tablet, enteric coated tablet should be administered in whole form Broken or crushed form of the enteric coated tablet causes destruction of the drug by gastric juice or irritation to the stomach. Enteric coated tablet is comparatively expensive.

Film coated tablet-The tablet that is covered with a thin layer or film of polymeric substance which protects the drug from atmospheric conditions and mask the objectionable taste and the odor of drug.

Implant-A small tablet that is prepared for insertion under the skin by giving a small surgical cut into the skin which is stitched after the insertion of the tablet. This tablet must be sterile one. The drug used in this preparation is usually water insoluble and the tablet provides a slow and continuous release of drug over prolonged period of time ranging from 3 to 6 months or even more Contraceptive tablet is formulated as implant.

Sugar coated tablet-The tablet that contains active ingredient(s) of unpleasant taste may be covered with sugar to make it more palatable. This type of tablet should be administered in whole form, otherwise the patient will experience the unpleasant taste of the active ingredient.

Modified release tablet-Modified-released tablet is either uncoated or coated. This contains special additives or prepared by special procedure which, separately or together, is intended to modify the rate of release of the drug into the gastrointestinal tract. It prolongs the effect of drug and also reduces the frequency of administration of drug. Several drugs are available in modified release tablet such as indomethacin.

There is another term popularly known as pill. Once the people’s idea was to use of pill in every ill. Now days the term has been only used in contraceptive preparations such as combination pill, minipill, and morning after pill.

WHAT IS CAPSULE AND TYPES OF CAPSULE?

Capsules are gelatin containers that contain medicines. These are common pharmaceutical dosage forms those are easy to manufacture. Capsules do not require any complex formulation to manufacture.

Capsules are of following two types:

1. Soft gelatin capsules

2. Hard gelatin capsules

1. Soft Gelatin Capsules: These are also called as softgel. Soft gelatin capsules are manufactured as single piece capsule shell. These capsules are suitable for non-aqueous solution such as oils. Active ingredients are dissolved or suspended in oily base. Manufacturing and filling of soft gelatin capsules are done same time in same machine. Content of capsule is filled during the manufacturing the shell. These capsules melt within the minutes in the stomach releasing the content having within it. These contain 5% to 14% of moisture content. Sometimes soft gelatin capsules are printed with brand names or strengths.

2. Hard Gelatin Capsules: Hard gelatin capsules consist of two parts, one is body and other is cap of capsules. These are supplies in closed condition but without locking. Generally body and cap has different colors. Hard gelatin capsules are dry in nature and active ingredients are filled in powder form in the hard gelatin capsules. Body part of capsule is filled, closed by cap and locked by pressing genteelly by the capsule machines or manually. These are disintegrated in 3 minutes and release the content. These are hygroscopic in nature and contain 12% -16% of moisture. Sometimes it is required to release the drug at any target then hard gelatin capsules are filled with target release pellets. In some cases tablets are also filled in the gelatin capsules.

Gelatin capsule shells have great potential of microbial growth because of its nutritional quality. So it is important to analyze the gelatin shells for microbial contamination. Gelatin is manufactured from the animal bones. Vegetarian capsules are manufactured from hypromellose – a polymer of cellulose.

Defects of capsules in filling with their picture  

Capsules are having different sizes according to the requirements. Capacity of capsules varies from 0.13 ml to 28 ml. Following is list of the different sizes of capsule shells.