Non-Sterile Manufacturing

Introduction
A non-sterile manufacturing area refers to a
designated space within a pharmaceutical or
healthcare facility where the production and
packaging of non-sterile products take place. Non-
sterile products are those that do not require a
sterile environment to maintain their efficacy and
safety.

Non-sterile manufacturing areas are designed and

maintained to meet specific quality and regulatory
standards to ensure the production of safe and
effective products. These areas are commonly
used for the manufacturing of tablets, capsules,
liquids, creams, ointments, powders, and other
similar pharmaceutical forms.
key considerations for non-sterile manufacturing areas include:

01 02 03
Environmental Equipment Good Manufacturing
controls Practices

04 05 06
Cleaning and Personnel others
sanitization training
01
LIQUID ORALS
 LIQUID ORALS
Liquid orals, also known as oral liquids, refer to pharmaceutical formulations that are designed to be administered orally
in a liquid form. These formulations are intended for ingestion and are commonly used for pediatric and geriatric
patients, as well as individuals who have difficulty swallowing solid dosage forms such as tablets or capsules.

Liquid orals can be classified into different categories based on their composition and intended use. Some common types
of liquid orals include:

1. Syrups: Syrups are concentrated solutions of active pharmaceutical ingredients (APIs) in a sweetened vehicle. They
are often flavored to improve palatability and may contain additives such as preservatives and coloring agents. Syrups
are commonly used for cough and cold medications, antihistamines, and expectorants.

2. Elixirs: Elixirs are clear, sweetened hydroalcoholic solutions that contain APIs. They typically have a higher alcohol
content compared to syrups and may also contain other solvents or cosolvents. Elixirs are commonly used for oral pain
medications, antacids, and cough suppressants.
3. Suspensions: Suspensions consist of finely dispersed solid particles of APIs in a liquid vehicle. The particles
are not completely dissolved, and they tend to settle over time, requiring shaking before administration.
Suspensions are commonly used for antibiotics, antacids, and analgesics.

4. Solutions: Solutions are clear, homogeneous mixtures of APIs in a liquid vehicle. Unlike suspensions,
solutions have completely dissolved APIs and do not require shaking before administration. Solutions are
commonly used for antiseptics, antifungals, and antihypertensives.

Liquid orals are manufactured in accordance with Good Manufacturing Practices (GMP) guidelines to ensure
product quality, safety, and efficacy. The formulations are developed to provide accurate dosing, good stability,
and acceptable taste to enhance patient compliance.

NB : Labelling information's has to be followed

02
BULK CONCENTRATE
 BULK CONCENTRATE
Bulk concentrate in the context of pharmaceuticals refers to a concentrated form of a drug or active pharmaceutical ingredient
(API) that is produced in large quantities. It is a highly potent or concentrated form of the drug, typically in powder or liquid
form.

The purpose of producing bulk concentrate is to facilitate further processing, formulation, or manufacturing of pharmaceutical
products. By producing the drug in a concentrated form, it allows for efficient transportation, storage, and handling of large
quantities of the API.

Bulk concentrate is often diluted or further processed during the manufacturing of final dosage forms such as tablets, capsules,
or solutions. Dilution is typically done to achieve the desired potency or concentration required for the final product.

In addition to convenience in transportation and storage, bulk concentrate may offer cost benefits in terms of production
efficiency and reduced packaging requirements.

It is important to note that the handling and processing of bulk concentrate should be done in accordance with strict quality
control measures and safety protocols, as it involves highly potent or concentrated substances. Proper handling, storage, and
dilution procedures must be followed to ensure safety and accuracy during manufacturing processes.
03
PROCUREMENT OF
STORES AND TESTING OF
RAW MATERIALS
 Procurement of Stores

Procurement of stores and testing of raw materials are important processes in the pharmaceutical industry to ensure the quality,
safety, and efficacy of the final pharmaceutical products. Let's discuss each process in more detail:

Procurement of Stores:
The procurement of stores refers to the process of sourcing and acquiring various materials, supplies, equipment, and
components needed for the pharmaceutical manufacturing and testing processes. This can include items such as chemicals,
solvents, packaging materials, laboratory equipment, and other consumables.
Key steps involved in the procurement process may include:
• Identifying the requirements: Determining the specific needs of the organization, taking
into account production plans, quality standards, and regulatory requirements.
• Vendor selection: Evaluating and selecting reliable suppliers or vendors based on factors
such as quality, reliability, price, delivery timelines, and compliance with regulations.
• Request for Quotation (RFQ) or Request for Proposal (RFP): Issuing RFQs or RFPs to
potential suppliers to gather pricing and technical information.
• Evaluation and negotiation: Assessing the received quotations or proposals, conducting
supplier evaluations, negotiating terms, and finalizing contracts or purchase orders.
• Receipt and inspection: Receiving the procured items, verifying their quality, quantity, and
compliance with specifications.
• Inventory management: Proper storage, labeling, and control of the procured stores to
ensure their availability when needed and to prevent wastage or expiration.
 Testing of Raw Materials

The testing of raw materials is a critical quality control step to ensure the
suitability and quality of incoming materials used in pharmaceutical
manufacturing. Raw materials include active pharmaceutical ingredients
(APIs), excipients, solvents, and other components that go into formulating
the final pharmaceutical products.
 Testing of Raw Materials
The testing process typically involves the following steps:
• Sampling: Taking representative samples from each batch or lot of the raw
material for testing purposes.
• Identity testing: Confirming the identity of the raw material using techniques
such as spectroscopy, chromatography, or other specific tests.
• Quality testing: Analyzing the raw material for its quality attributes, including
purity, potency, impurities, microbial contamination, particle size distribution,
and other relevant parameters as per established specifications or compendial
methods.
• Documentation: Maintaining proper documentation of the testing process, test
results, and any deviations or corrective actions taken.
 Testing of Raw Materials
• Release or rejection: Based on the test results, raw materials are either approved
for use in manufacturing or rejected if they do not meet the required
specifications.
• Retesting and revalidation: In case of any discrepancies or out-of-specification
results, appropriate actions such as retesting or investigation may be undertaken
to determine the root cause and establish the material's suitability for use.
Testing of raw materials ensures that only high-quality materials are used in the
manufacturing process, thereby safeguarding the quality and efficacy of the
final pharmaceutical products.
 Testing of Raw Materials

Both the procurement of stores and the testing of raw materials are crucial
components of the pharmaceutical supply chain and quality control
processes. They contribute to the overall quality assurance and compliance
with regulatory requirements in the pharmaceutical industry.
04
03
NOMENCLEATURE AND
USE OF SURGICAL
INSTRUMENTS
NOMENCLEATURE AND USE OF SURGICAL
INSTRUMENTS

Surgical instruments are specialized tools or devices used by healthcare

professionals during surgical procedures to perform specific tasks. These
instruments are designed for various purposes and have specific names and
nomenclature associated with them. Let's explore the nomenclature and
common uses of surgical instruments:
NOMENCLEATURE AND USE OF SURGICAL
INSTRUMENTS
1. Scalpel: A scalpel is a sharp, precision cutting instrument used for making incisions
or excisions in tissue during surgical procedures.
2. Forceps: Forceps are handheld instruments with two blades and a handle. They are
used for grasping, holding, or manipulating tissues or other surgical materials.
Examples include tissue forceps, hemostatic forceps, and dressing forceps.
3. Scissors: Surgical scissors are used for cutting tissues, sutures, or bandages. They
come in various shapes and sizes, such as straight scissors, curved scissors, and
dissecting scissors.
4. Retractors: Retractors are used to hold tissues or organs aside, providing access and
visualization of the surgical site. They can be self-retaining or handheld, and
examples include abdominal retractors, rib retractors, and wound retractors.
NOMENCLEATURE AND USE OF SURGICAL
INSTRUMENTS
1. Clamps: Clamps are used to occlude blood vessels, control bleeding, or hold tissues
in place. They come in different designs, such as artery forceps, mosquito forceps,
and Kelly clamps.
2. Needle Holders: Needle holders are used to grasp and manipulate surgical needles
during suturing. They have a locking mechanism to securely hold the needle,
allowing precise control during stitching.
3. Probes and Dilators: Probes are slender, pointed instruments used for exploring
wounds, body cavities, or organs. Dilators are used to gradually enlarge or dilate an
opening, such as a blood vessel or a urethra.
4. Retractors: Retractors are used to hold tissues or organs aside, providing access and
visualization of the surgical site. They can be self-retaining or handheld, and
examples include abdominal retractors, rib retractors, and wound retractors.
NOMENCLEATURE AND USE OF SURGICAL
INSTRUMENTS

1. Suction Devices: Suction devices are used to remove fluids, blood, or debris from
the surgical field to maintain visibility. They can be manual or powered and are
often connected to a suction system.
2. Electrocautery Devices: Electrocautery devices use heat or electricity to coagulate
tissues, control bleeding, or make precise incisions. They are commonly used in
various surgical procedures.
05
03
HOSPITAL EQUIPMENT
AND ACCESSORIES
HOSPITAL EQUIPMENT AND ACCESSORIES

Hospital equipment and accessories encompass a wide range of tools, devices, and
accessories used in healthcare settings to facilitate patient care, diagnosis,
treatment, and monitoring. Here are some common examples:

1. Patient Beds: Hospital beds are designed to provide comfort and support to patients
during their stay. They often include adjustable features for positioning and may
have additional functions such as electronic controls, side rails, and built-in scales.
HOSPITAL EQUIPMENT AND ACCESSORIES
1. Examination Tables: Examination tables are used in medical examination rooms to
facilitate patient assessment. They typically have an adjustable height and a padded
surface for patient comfort.
2. Infusion Pumps: Infusion pumps are used to administer fluids, medications, and
nutrients intravenously at a controlled rate. They ensure accurate delivery and may
have additional features for multiple channels or programmable dosing.
3. Vital Signs Monitors: Vital signs monitors are used to measure and display essential
patient parameters, including heart rate, blood pressure, temperature, and oxygen
saturation. They provide real-time monitoring and aid in early detection of
abnormalities.
HOSPITAL EQUIPMENT AND ACCESSORIES
1. Examination Tables: Examination tables are used in medical examination rooms to
facilitate patient assessment. They typically have an adjustable height and a padded
surface for patient comfort.
2. Infusion Pumps: Infusion pumps are used to administer fluids, medications, and
nutrients intravenously at a controlled rate. They ensure accurate delivery and may
have additional features for multiple channels or programmable dosing.
3. Vital Signs Monitors: Vital signs monitors are used to measure and display essential
patient parameters, including heart rate, blood pressure, temperature, and oxygen
saturation. They provide real-time monitoring and aid in early detection of
abnormalities.
HOSPITAL EQUIPMENT AND ACCESSORIES
1. Diagnostic Imaging Equipment: This includes devices such as X-ray machines,
computed tomography (CT) scanners, magnetic resonance imaging (MRI) scanners,
ultrasound machines, and mammography machines. These tools are used for
visualizing internal structures and aiding in diagnosis.
2. Anesthesia Machines: Anesthesia machines deliver a precise mixture of gases and
anesthetic agents to patients undergoing surgery or other procedures requiring
anesthesia. They often include monitors for respiratory and cardiovascular
parameters.
3. Surgical Instruments: As discussed earlier, surgical instruments such as scalpels,
forceps, scissors, retractors, and clamps are essential tools used during surgical
procedures.
HOSPITAL EQUIPMENT AND ACCESSORIES
1. Ventilators: Ventilators provide respiratory support to patients who have difficulty
breathing. They deliver controlled amounts of oxygen and assist with mechanical
ventilation.
2. Wheelchairs and Stretchers: Wheelchairs and stretchers are used for patient
transportation within healthcare facilities. They provide mobility and ensure patient
comfort during transfers.
3. Medical Carts and Trolleys: Carts and trolleys are used for storing and transporting
medical supplies, medications, and equipment within the hospital. They allow for
efficient organization and accessibility.
HOSPITAL EQUIPMENT AND ACCESSORIES
1. Ventilators: Ventilators provide respiratory support to patients who have difficulty
breathing. They deliver controlled amounts of oxygen and assist with mechanical
ventilation.
2. Wheelchairs and Stretchers: Wheelchairs and stretchers are used for patient
transportation within healthcare facilities. They provide mobility and ensure patient
comfort during transfers.
3. Medical Carts and Trolleys: Carts and trolleys are used for storing and transporting
medical supplies, medications, and equipment within the hospital. They allow for
efficient organization and accessibility.
Q&A
 What is the purpose of procurement
in the pharmaceutical industry?

To provide training for healthcare

professionals

Q&A To source and acquire materials for

manufacturing and testing processes

Conducting medication research and

development

To conduct research and development

for new medications.
 What are the key steps involved
in the procurement process?

Inventory management, product

labeling, and storage control

Q&A Identifying requirements, vendor

selection, and evaluation and
negotiation

Conducting clinical trials, analyzing test

results, and releasing the product

Manufacturing, packaging, and

distribution
 Why is testing of raw materials important
in the pharmaceutical industry?

To market the product more effectively

Q&A To meet regulatory requirements

and quality standards

Conducting clinical trials, analyzing test

results, and releasing the product

To speed up the production process

 What is the purpose of producing bulk
concentrate in the pharmaceutical
industry?

To market the product more

commercially

Q&A To reduce the cost of production

To market the drug more

effectively

To speed up the production

process
 Why is proper handling and storage of
bulk concentrate important?

To extend the shelf life of the

drug

Q&A To ensure safety and accuracy

during manufacturing processes

To achieve the desired

concentration of the final product

To speed up the production

process
 Why is proper handling and storage of
bulk concentrate important?

To extend the shelf life of the

drug

Q&A To ensure safety and accuracy

during manufacturing processes

To achieve the desired

concentration of the final product

To speed up the production

process
 Which type of liquid oral formulation contains
finely dispersed solid particles that may
require shaking before administration?

Solutions

Q&A Suspensions

Elixer

Tablets
 Why are liquid orals commonly used for
pediatric and geriatric patients?

They have a longer shelf life

compared to solid dosage
forms.
Q&A They provide accurate dosing
and are easier to swallow.

They offer a higher potency of

active pharmaceutical
ingredients (APIs).
They have a faster onset of
action compared to other
formulations.