PHARMACEUTICAL LABORATORY

Edilyn ATIENZA , Kim BEJENIA, Kimberly CARREON , Cassey

Khate GUAVEZ, Putri Rusdah MOKALID, Jeah Camille SEVILLENO
BET-ELEXT 3A
 SENSORS
Sensors that are involved in manufacturing
the pharmaceuti cal medicine.
pH Electrode are analytical sensors for measuring potential of hydrogen (pH), the negative
logarithm of the hydrogen ion activity in solution.

Biolab FRE DRPAD100 Drip Sensor has an optical sensor designed to measure the number of
drops poured during a dosage. It can automatically convert the number of drops poured into
volume.

Biomedical Sensor are tools that detect specific biological, chemical, or physical processes and
then transmit or report this data. ... Biomedical Sensors are also often used to monitor the safety
of medicines, food, environmental conditions, and other substances we may encounter.
P R O D U C T I O N O F M A N U FAT U R I N G

The study aims to evaluate the influence or the impact of 26 weeks of

combined aerobic and resistance-training (CART) exercise on bone
mineral density (BMD) in a convenience sample of female cancer
survivors.
 F E R M E N TAT I O N
Fermentation is a biochemical process employing selected micro-organisms and
microbiological technologies to produce a chemical product. Batch fermentation processes involve
three basic steps: inoculum and seed preparation, fermentation, and product recovery or isolation
(Theodore and McGuinn 1992).
PHAR MACE U TICAL MANU FACT URIN G OF D OSA GE
FORM S
Drug substances are converted into dosage-form products before
they are dispensed or administered to humans or animals. Active
drug substances are mixed with pharmaceutical necessities, such
as binders, fillers, flavoring and bulking agents, preservatives and
antioxidants. Tablets and capsules are very common oral dosage
forms; another common form is sterile liquids for injection or
ophthalmic application.
 G R A N U L AT I O N
Dry and wet solids are granulated to change their physical properties. Granulators have different
designs and features with varying containment and control of mechanical hazards and airborne
dusts and vapours (Perry 1984; Swarbick and Boylan 1996). Enclosed granulators can be vented to
air-control devices, reducing emissions of solvent vapours or dusts to the workplace and
atmosphere .

Figure 79.10 A high steam granulator

 DRYI NG
Water- or solvent-wet solids are dried during many pharmaceutical manufacturing operations.
Dryers have different designs and features with varying containment and control of vapours and
dusts. Flammable solvent vapours and explosive airborne dusts may create flammable or explosive
atmosphere; explosion relief venting is particularly important on contained dryers.

Figure 79.11 A rotary

vacuum dryer
Glatt Air Figure 79.12 A vacuum
Techniques, Inc. shelf dryer
Source: EPA 1993
 DRYI NG
Milling: Dry solids are milled to change their particle characteristics and produce free-flowing
powders. Mills have different designs and features with varying containment and control of
mechanical hazards and airborne dusts (Kroschwitz 1992; Perry 1984).

Blending: Dry solids are blended to produce homogeneous mixtures. Blenders have different
designs and features with varying containment and control of mechanical hazards and airborne dusts
(Kroschwitz 1992; Perry 1984).

Compression: Dry solids are compressed or slugged to compact them, changing their particle
properties. Compression equipment has different designs and features with varying containment and
control of mechanical hazards and airborne dusts (Gennaro 1990; Swarbick and Boylan 1996).
 TA B L E T S A N D
CAPSULES
Tablets and capsules are the most common oral dosage
forms. Compressed or molded tablets contain mixtures of
drug substances and excipients. These tablets may be
uncoated or coated with solvent mixtures or aqueous
solutions. Capsules are soft or hard gelatin shells. Tablet
presses, tablet-coating equipment and capsule-filling
machines have different designs and features with varying
containment and control of mechanical hazards and
airborne dusts (Cole 1990).

Figure 79.13 Tablet press with load hopper and spiral dust pickups  for product recovery
 TA B L E T S A N D
CAPSULES
Tablet-coating equipment can be vented to air emission devices to control VOCs from the process.
Modern tablet presses and capsule-filling machines are enclosed by interlocked panels, reducing
the hazards of fast-moving parts, high noise levels and dust emissions during their operation.
Hearing-protective devices can reduce worker noise exposures during tablet and capsule
operations.

Figure 79.14 A tablet coating machine

Source: Perry 1984
 PHARMACEUTICAL
PA C K A G I N G
Pharmaceutical packaging operations are performed with a series of integrated machines
and repetitive manual tasks (Gennaro 1990; Swarbick and Boylan 1996). Finished dosage-
form products may be packaged in many different types of containers (e.g., plastic or glass
bottles, foil blister packs, pouches or sachets, tubes and sterile vials). The mechanical
equipment fills, caps, labels, cartons and packs the finished products in shipping containers.
Worker proximity to packaging equipment necessitates barrier guarding on moving machine
parts, accessible control switches and emergency stop cables and employee training on
machine hazards and safe work practices. Enclosure and isolation of equipment reduces
sound and vibration levels in packaging areas.

Reference:
Chapter 79 - Pharmaceutical Industry (ilocis.org)
 TERMS IN PHARMACEUTICAL
I N D U S T R Y:
Ethical pharmaceuticals are biological and chemicals agents for preventing, diagnosing or
treating disease and disorders in humans or animals. These products are dispensed by
prescription or approval of a medical, pharmacy or veterinary professional.

Drugs are substances with active pharmacological properties in humans and animals.
Drugs are compounded with other materials, such as pharmaceutical necessities, to produce
a medicinal product.

Pharmacokinetics is the study of metabolic processes relating to the absorption,

distribution, biotransformation, and elimination of a drug in humans or animals.

Pharmacodynamics is the study of drug action relating to its chemical structure, site of
action, and the biochemical and physiological consequences in humans and animals.
M E T H O D S U S E D I N TA B L E T
F O R M U L AT I O N

Wet granulation,
Dry granulation, or
Direct compression.
 W E T G R A N U L AT I O N

Wet granulation is a widely used method to produce compressed tablet. It is essentially a process
of size enlargement involving several steps and the use of an adhesive substance known as binder.
The granules produced using this method of granulation has a greater probability of meeting all
the physical requirements for tablet formation.
 DRAG FORCE FLOW (DFF)
Drag Force Flow (DFF) sensor is a thin, hollow, cylindrical needle, approximately 1-4 mm
diameter, which provides real-time measurement of the local flow forces within the in-process
material when mounted inside mixers, granulators, feeders, or other processing equipment.

Figure 1. Drag Force Flow Sensor

 Figure 2. In-line sensor installation within a
granulator

Figure 3. FT4 Powder Rheometer®

Real-Time In-Line Monitoring of High Shear Wet Granulation | American Pharmaceutical Review - The Review of American
Pharmaceutical Business & Technology
 D R Y G R A N U L AT I O N
Dry Granulation is used when tablet excipients have sufficient inherent binding properties. The
procedure can also be used as a means to avoid exposure of drug substances to elevated
temperatures (during drying) or moisture. Double compression method eliminates a number of steps
but still includes weighing, mixing, slugging, dry screening, lubrication, and compression of
granules into tablets. Compaction for the dry granulation process is generally achieved either by
slugging or roller compaction.
 DIRECT COMPRESSION
Direct compression involves direct compression of powdered materials into tablets without
modifying the physical nature of the materials itself. The technology involved in this method
assumes great importance in the tablet formulations, because it is often the cheapest means,
particularly in the production of generics that the active substance permits.
 WORD PROBLEM
Using the method of Wet Granulation in producing compressed medicine tablets, when the technologists pushed the start
button, the drug granules will pass through the Drag Force Flow (DFF) sensor and be grinded for 5 seconds on the grinder
machine and stops as it proceed to the binder solution for 10 seconds in the blending machine with the Adjuvant. And
after, the Mixing of binder solution of liquids forming agglomerate with powders were to form a damp mass for 15 seconds
while the pH Electrode is sensing the hydrogen ion activity in the solution. Then, a screening will undergo in the dampened
powder into pellets or granules (wet screening) using the 6- to 12-mesh screen for 20 seconds. The finished product will now
proceed in to the rotary vacuum dryer to dry moist granules for 5 seconds. And as the dryer process has ended, sizing of
granulation by dry screening using 14- to 20-mesh screen will take place for 10 consecutive seconds. As the last process
have reached its end, the Blending Machine together with the lubricant will eventually start to mix dried granules for 15
seconds. And lastly, the compressor will start compressing the granules into for 20 seconds therefore resulting in a finished
product of medicine tablets. And as the stop button is pressed, all the outputs of Wet Granulation will proceed in operation
delay (stop) And the Dry Granulation procedure will now start.
 WORD PROBLEM
The drug will proceed to the grinder machine or Oscillating granulator and works for 5 seconds and then blend
it with the Adjuvant in the blending machine for 10 seconds and stops and proceed to the pellet for 5 seconds.
And then proceeds to the crushing machine for 5 secs and the sizing of granulation will be taken place in the
dry screening using 14- to 20-mesh screen for 10 consecutive seconds. The blending machine will turn on as
screening has ended along with the Biolab FRE DRPAD100 Drip Sensor to measure the number of drops of
lubricant poured for 5 seconds and as it properly reached its end, the compressor will turn on and starts
compressing the particles and the Biomedical sensor will work as it detects the chemical properties of the
processed drug granules called tablets in 15 seconds. As the Technologists sensed a negative behavior on the
chemical data gathered and converted to electronic data, the technologists push the Emergency Stop button to
eliminate further destruction on the chemical attributes of the drug granules and to immediately create an action
to the anomalies.
 INPUT/OUTPUT NAMES
Legends in Manufacturing of Pharmaceutical Medicines in a Laboratory PLC Programming using
the Ladder Diagram:
LOGO! Allocation Description LOGO! Allocation Description
I1 Start Push Button Q1 Grinder Machine
I2 Stop Push Button Q2 Blender Machine
I3 Reset Button
Q3 Adjuvant
I4 Emergency Push Button
Q4 Agglomerate
I5 Drug Granules
I6 Drag Force Flow (DFF) Q5 Liquids
sensor Q6 Pellet
I7 pH Electrode Q7 Rotary Dryer Machine
I8 Oscillating granulator
Q8 Screen
I9 Biolab FRE DRPAD100
Drip Sensor Q9 Lubricant
I10 Biomedical Sensor Q10 Compressor Machine
 INPUT/OUTPUT NAMES
Legends in Manufacturing of Pharmaceutical Medicines in a Laboratory PLC Programming using
the Ladder Diagram:
LOGO! Allocation Description
Q11 Tablet
Q12 Dry Granulation Grinder
Q13 DG Blender
Q14 DG Adjuvant
Q15 DG Pellet
Q16 DG Crusher
Q17 DG Screen
Q18 DG Blender
Q19 DG Lubricant
Q20 DG Compressor