Manufacturing Of Antibiotics: The Complete FAQ Guide In 2025

You often observe that antibiotics are available in powder form and sterile water is added in it before administration. Can you guess why? These antibiotics are very sensitive and can become unstable in liquid form during shelf life. There is always strong chance of growth of microorganism in liquid state. Such facts convince the formulation of product in lyophilized/ freeze-dried form.

Example: penicillin, fosfomycin, etc.

Some formulations of antibiotics are produced in liquid state and reasons can be very clear. These antibiotics have capacity to remain stable during shelf life, these are heat-stable and you find them unchangeable even storing in liquid form. Example: Nafcillin

This class works by inhibiting the cell wall synthesis of bacteria and you find it effective for many infections.

Uses:

You can use penicillin to treat ear and throat infection, rheumatoid fever, urinary tract infections

These antibiotics show their profound effect by interrupting the cell wall synthesis in bacteria. Fragile cell wall eventually leads to death of bacteria. They have wide spectrum and can be used against so many infections.

Uses:

These are used to cure sexually transmitted diseases like gonorrhea, reproductive system related infections or infection of brain you can called as meningitis.

Do you know bacteria needs protein to survive? Antibiotics of this class have capacity to inhibit protein synthesis of bacterial cell by attaching to50S ribosomal subunit.

Uses:

These antibiotics have great ability to fight against respiratory tract infections, infections related to ear, skin and sexually transmitted diseases.

These antibiotics are capable to stop protein synthesis in bacteria, just by binding to 30S subunit of ribosome. It is being used for many diseases that are caused by gram-negative bacteria.

Uses:

These are used to treat some important infections like tuberculosis, nosocomial respiratory tract infections, abdominal infections etc.

These antibiotics can stop the integration of bacterial cell wall that causes fatality of bacteria. These are considered as broad spectrum and can treat variety of infections.

Uses:

Carbapenems are often used to manage infections related to respiratory tract, urinary tract, abdomen, skin, pelvic, brain etc.

These antibiotics have great tendency to stop DNA synthesis in bacteria, do you know how? By inactivating two important enzymes that are responsible for DNA production. This class of antibiotics comes under broad spectrum antibiotics, so they are utilized on the basis of their capability to fight different bacteria.

Uses:

Flouroquinolones are intended to treat pneumonia, sepsis, urinary tract infections, bone infections etc.

Such antibiotics work by limiting the synthesis of cell wall in bacteria. This hindrance can cause death of bacteria. You can often observe the use of these antibiotics to manage infections caused by gram positive bacteria.

Uses:

Glycopeptides antibiotics are used when other antibiotics have failed to cure serious infections. Do you know why? These antibiotics have ability to treat resistant strain of bacteria. They have been used to treat nosocomial infections, lower respiratory infections, bone infections, skin infections etc.

Such antibiotics act to affect the DNA and inhibit the synthesis of protein of bacterial cell wall.

Uses:

These are used to administer after surgery, or to treat serious lesions.

You can observe that antibiotics injections are available in vial either single dose or multiple doses.

These vials are capable to store antibiotics without affecting their stability or sterility.

Vials also offer the ease to draw precise dose and without causing any contamination.

Vials follow guidelines given by good manufacturing practices for packaging antibiotics.

You can see vials are made of glass or plastics.

Antibiotics that are intended to be given as single dose as they don’t contain preservatives, you can use ampoules.

Ampoules can ensure you proper sterility and stability of product.

You don’t expect chemical instability due to packaging in ampoules.

Most commonly, you often find glass ampoules for antibiotics packaging.

You often observe IV antibiotics come in BFS bottles that are mixed with vehicle to form liquid formulation.

These are plastic containers that you find convenient to carry and use.

Packaging process of packing antibiotics in BFS bottle is so secure that there are minimum chances of contamination in the product.

This container offers the best way to administer sterile and accurate dose of antibiotics.

You fill liquid formulation in pre-filled syringes and you don’t need to worry about its stability as you have to follow storage instructions to keep it stable.

Do you know about its storage temperature? Pre filled syringes are stored at freezing temperature like -20C to keep them stable for long time. Refrigeration keeps formulation stable for few days.

No it is not like that. First you need to decide which bacteria or fungi you need to source antibiotics from, as every antibiotic comes from distinct source.

For fermentation process, you need three things; high-grade microbial strains, nutrients containing culture to grow the strain and fermentation tanks.

These fermentation tanks are specialized equipment that maintains the temperature, pH, and nutrients during growth of microbial strain.

You have to wait for three to seven days to complete the fermentation process.

After the cultivation of microorganism, you perform the next step to extract the antibiotics.

You obtain the broth when fermentation process gets over and you can use Centrifuges to separate cells of microbes from the broth.

The portion that is in liquid form, you can find antibiotics over there; you can use different processes like solvent extraction, precipitation or adsorption to extract antibiotics.

For this purpose you perform some methods to get pure form of antibiotics.

This antibiotic will be used as active pharmaceutical ingredient to formulate the final product.

Purification methods that can be used by you include crystallization, chromatography or filtration by the help of membrane.

Crystallization is helpful as you get the purest form of antibiotic in crystallized form, chromatography is a fine method to get the high-grade antibiotic and filtration is carried out by passing antibiotic from membrane to retain endotoxins and unwanted particles.

First you are required active pharmaceutical ingredient, vehicle, stabilizer or preservatives to formulate the antibiotics.

Vehicle that is useful for you is sterile water for injection, which you source from water treatment system.

Active pharmaceutical ingredient is mixed with sterile water by using a mixing vessel. After that you can add other ingredients. The mixing process will be continued until you obtain a well-mixed solution.

This mixing tank has the ability to keep the suitable temperature during the process and stirrer is utilized for proper mixing.

You can see that filling and sealing machines works on almost same principle and their goal is to fill and seal antibiotics in specific container with great accuracy. All of these machines are fully automated and capable of maintaining aseptic environment during operation.

First you can observe that the packaging containers are washed and sterilized, then subjected to be filled by the help of filling nozzles. After filling, you put the container for sealing.

Different containers have their own particular way of sealing like vials are sealed by putting rubber stoppers crimped with aluminum caps.

Ampoules are sealed by using flame. Thin top neck of ampoule is melted through heat and gets air-tight seal.

BFS bottle is sealed by the aid of heat or mechanical jaws.

Antibiotics that are delicate to store in liquid form, you have to change their form into powder to keep them stable during shelf life.

Process of lyophilization is very simple, initially you froze the drug formulation and then apply pressure to remove water content from in int. this method provides you powder form antibiotic directly from frozen state.

This powder form can be known as freeze dried powder.

Lyophilizers are the part of manufacturing of antibiotics and vials are subjected to lyophiliozers after filling and sealing.

Antibiotics are subjected for final sterilization in autoclaves.

You can assess the quality by performing different tests like potency test, sterility test, purity test etc.

You can firstly apply labels by using labeling machine. Labels must be applied with precision, wrong labels can put consumer in serious consequences.

Packaging of dispensing container is counted as integral step to keep formulation stable and sterile during storage and distribution.

You can utilize cartoning machine for this packaging of containers into appropriate sized boxes.

You have understood that the process of manufacturing of antibiotics start with fermentation process, for which you must require fermentation tanks.

This tank carries out the process of fermentation efficiently. You can observe that temperature, pH, and nutrients are remained in optimistic level to support the growth of microbes.

Do you know the purpose of centrifuge? This equipment uses centrifugal force to separate particles of a mixture. Liquid that contains antibiotic is made separated by the help of centrifuge.

This equipment is utilized in pharmaceutical industry to purify the substance. Here in this process, you use this technique to purify the extracted antibiotics.

During whole process, you require sterile water. This water is made sterile by the help of water treatment system. This system ensures the purity of water.

Aipak Water Treatment System

All ingredients need to be mixed well, for mixing process, you use mixing tank that contains stirrer and temperature controlling system.

Filtration before filling is quite necessary to secure the sterility of formulation. You can use sterile filter that contains a membrane which retains impurities and microbes and allows only formulation.

You find pre-filled syringe production line easy to function as it performs all steps automatically.

You can observe that, the process starts when disposable syringes are loaded, then these are made unpacked and torn up to get filled with formulation. After filling syringes are plugged to make them secure and safe.

Aipak Pre Filled Syringe Production Line

Vial filling machine for lyophilized powders is designed for precise and aseptic filling and sealing of antibiotics in vials.

You find this machine so convenient and efficient to use.

This machine comprises of four important parts that are washing unit, sterilization unit, filling and stoppering unit and capping unit.

Aipak Vial Filling Machine For Lyophilized Powder

Vial filling machine for liquid machine is fully automated and well equipped machine, that is formed by incorporating four different machines that are

Washing machine

Sterilizing machine

Filling and stoppering machine

Capping machine

Aipak Vial Filling And Sealing Machine For Liquids

Antibiotics that are produced in powder due to instability issues, you require lyophilizer for them.

Liquid formulation of antibiotics changes into freeze dried powder form by using lyophilizer.

Ampoule filling machine is fully automated and performs each step efficaciously to fill and seal the ampoules.

You can see the machine is comprised of washing and sterilizing unit, filling station and sealing unit.

Aipak Ampoule Filling And Sealing Machine

BFS bottle filling machine functions automatically and with great accuracy.

You can see the process starts with formation of plastic bottle, which passes to sterilizing, filling and sealing units one by one. 

Aipak BFS Bottle Filling And Sealing Machine

Autoclave is the convenient mean of sterilizing formulations in pharmaceutical industry. When you fill and seal the antibiotics in dispensing container, you can put the container in autoclave for final sterilization.

This machine uses steam to sterilize the formulation and it comes with ability to protect heat-sensitive formulations from getting damaged.

Aipak Autoclave

Labels are printed and applied by the help of labeling machine.

You can see it utilizes adhesive technique to apply labels on vials.

Aipak Labeling Machine

Cartoning machine has the purpose of packaging final products of antibiotics into boxes. Some boxes have space for single product and some boxes have multiple compartments to package more than one product.

Aipak Cartoning Machine

You have to perform all functions in a clean room to avoid any contamination.

Do you have idea what these clean rooms have? These clean rooms have temperature and humidity in optimized limit and air is unpolluted. Such conditions are maintained by the help of HVAC system.

You perform every process by wearing a specialized costume to prevent contamination by human touch.

This system is behind the controlled environment of clean room. You can find it working in different ways like, it makes air free from unwanted particles and microbes, maintains temperature and humidity and distributes the filtered air throughout the clean room.

You often look at filling and sealing equipment and found this restricted access barrier system (RABS). This system helps you to prevent contamination during chief process of filling and sealing of antibiotics.

You find this system very useful for cleaning or sterilizing any machine without moving it to other place. For example, you can sterilize fermentation tanks by the help of this system.