Hormone Manufacturing Facility Guidelines: The Complete FAQ Guide In 2025

You should look after that the given guidelines are covering every important aspect and they must be competent to regulatory standards suggested by different regulatory bodies like FDA.

Picture Courtesy: C&EN

You must have a separated are for hormone manufacturing and this area also must be divided in segregated portions for carrying out the process such as a place to handle ingredients, a place to perform mixing etc.

If you are carrying out production of different hormones, so make sure they also have separate manufacturing facility.

Keep one thing in your mind that this manufacturing area must have clean rooms, where you can maintain aseptic conditions.

Picture Courtesy: NGS Cleanrooms

This systems works behind the controlled environment of clean rooms.

It provides you fresh air in that manufacturing area and HEPA filters are there to keep air sterile.

You may notice that temperature, humidity, presence of microorganism and unwanted particles, all the things are managed by this system.

Picture Courtesy: Lindstorm Group

Material which is using in manufacturing must be of high-grade quality and sourced from a reliable supplier. Material must be passed in single-directional form to nullify the risk of contamination.

You can see that the working staff is restricted to wear gowns, to prevent any hazard to them as hormones can be dangerous. This costume also play role in minimizing the contamination risk.

Working staff is trained sensibly about handling the material and machines.

Working staff is got educated about the behavior they need to adopt in clean rooms.

Waste, which is produced after the completion of batch, is managed expertly by disposing it in a proper way.

Picture Courtesy: Armein Pharmaceutical Pvt. Ltd.

Machines are inspected for their competence with regulatory standards.

You can observe that different means like clean-in-place or sterile-in-place (CIP/SIP) and restricted access barrier system (RABS) are used to keep manufacturing process sterile.

Machines are checked for faults according to prepared schedule.

Cleaning of machines and production area is carried out by authentic ways, even oxidizers or detergents are used for cleaning. Swab test can be performed to check presence of particles.

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Information of every batch must be recorded and documented to avoid trouble in future and also you can trace the problem if it will happen.

Picture Courtesy: Zivon Lifecare

You perform different tests that confirm about the quality of final product, these tests can be performed to check purity, potency, sterility, microbial content or impurity etc.

It is a peptide hormone and available in market with different names like regular insulin, insulin glargine etc.

It is administered by subcutaneous (SC) route but in emergency you can give it by intravenous (IV) route.

It has ability to fasten the vaginal delivery and minimizing the bleeding after child birth.

You can introduce it in body by intra venous (IV) or intra muscular (IM) route.

It shows significant contribution in conception.

It is given intramuscularly (IM)

This hormone can be given by subcutaneous (SC) or intramuscular (IM) route.

Most of the time you can administer it by intramuscular (IM) route and sometimes subcutaneous (SC) route.

Physician recommends supplementation of human growth hormone by subcutaneous or intramuscular route in case of severe deficiency.

You can introduce the hormone into body by injecting into muscles.

This route offers you safe absorption of hormone without losing some amount by metabolism.

Common intra muscular sites can be deltoid muscle present in upper arm or you can administer in hip or thigh for profound effects.

Picture Courtesy: Pharmapproach.com

This route provides you safe but sustained route to introduce medication in body.

You inject drug in cutis layer of skin which is found beneath dermis and epidermis layer.

Picture Courtesy: Ausmed

This route works by introducing drug directly into blood vessel.

You find it very effective and rapid way of administering drug into the body.

Picture Courtesy: Active Plus Home Health Los Angeles

You must keep in mind that sourcing of raw material either its active ingredient or excipient, has great influence on quality of your final product, so always take this raw material from a reliable and recorded source.

Raw material must be of high-grade quality.

You must handle these hormones with care to avoid any toxicity.

Sterile water is sourced by using water treatment system.

You must note the thing that hormone is need to be dissolved in a sterile vehicle which has capability to dissolve it well. Like you can dissolve hydrophilic hormone in sterile water for injection or hydrophobic in lipid soluble solvent.

After dissolving the hormone, you have to add other ingredients like stabilizer, buffer, or preservative) and mix it uniformly.

Some formulations are suspensions or emulsions so they need to be homogenized well by using equipment like homogenizer, to form a uniform mixture.

Aseptic filling lines are the best to fill and seal hormones in desirable dispensing containers like ampoules, prefilled syringes or vials.

These filling lines are designed in such a way that supports the filling and sealing of specific container. You can observe that the machine follows the process by washing and sterilizing the containers, then filling it precisely and after that sealing it well to avoid contamination.

Lyophilization is a process in which you remove water content to convert it into powder. This process starts when formulation is made frozen, then pressure is applied to remove water. After that formulation changes to powder directly from frozen form.

You can call this powder as freeze-dried powder.

These tests may include potency test, purity test, sterility test, etc.

Such information may include traceability of ingredients, operator logs or maintenance log etc.

AIPAK Water Treatment System

This sterile water for injection has high purity and is considered as best sterile vehicle for most of the hormones.

This equipment uses 0.22 micron membrane to perform this process.

AIPAK Vial Filling Line For Liquids

This vial filling line composed of four important parts, that can be: washing machine, sterilization machine, filling and stoppering machine, and capping machine.

After filling with precise dose, vials are stoppered with rubber and capped by using aluminum or plastic caps.

AIPAK Vial Filling Line For Lyophilized Powder

This equipment has divided into washing unit, sterilization unit, filling and stoppering unit and sealing unit.

Vials are stoppered by using rubber and sealed by aluminum or plastic caps.

Formulations that lack the ability to remain stable in liquid form during storage conditions are changed to freeze dried form.

Lyophilizer performs the process of lyophilization and makes it easy for you to store hormone product in a stable form.

AIPAK Prefilled Syringe Production Line

It follows the process in a way that syringe is unpacked and then torn to get filled with hormone and after filling, plugging of syringe is carried out to make it air tight and avoid any contamination.

AIPAK Ampoule Filling Line

It consists of four machines that are washes, sterilizer, filling and sealing machine.

Sealing of ampoules is performed by using heat. Top part of ampoule is melted by using flame that helps in creating seal.

AIPAK Autoclave

AIPAK Labeling Machine

Adhesive method is used to apply the labels.

Labels contain important information like product name, dose, route of administration, batch number etc.

AIPAK Cartoning Machine

Hormones are packed in boxes, either single or multiple compartments to keep it safe during storage and distribution.

You must make sure that every step must be carried out in separate area.

You must check about the clean rooms as manufacturing of hormones require clean rooms that have controlled environment.

You must use all means to keep the environment aseptic and controlled like HVAC system, RABS (restricted access barrier system), etc.

You can assess the environment of manufacturing facility by taking samples and testing it.

Machines must be inspected and calibrated according to mandatory standards.

You must use suitable cleaning agents for cleaning purpose.

Machines can be cleaned or sterilized by using clean in place or sterilize in place systems.

Machines can be inspected by performing swabbing test, in which you swab and rinse a sample to check the hygiene standards.

You must always allow trained staff in hormone manufacturing premises.

You must implement CAPA in manufacturing facility to bring improvement in manufacturing facility of hormones.