Tablet Compression – A Comprehensive Overview

Tablet Compression Machine
Tablet Compression Machine

This article contains Comprehensive review on Tablet compression with Challenges and Solutions

Table of Contents

         Tablet Compression Challenges and Solutions

Tablet Compression Introduction :

Tablet Compression is a manufacturing process used to convert powdered or granulated pharmaceutical ingredients into tablets of a specific shape, size, and weight. This process involves compressing the ingredients into a solid dose form using a Tablet Compression machine.

Tablet compression is a critical step in the production of solid oral dosage forms, as it ensures that the active ingredients are uniformly distributed throughout the tablet and that the tablet has the required physical characteristics, such as hardness, disintegration time, and dissolution rate. Compression also ensures that the tablets are easy to handle, transport, and store.

The Tablet compression process involves feeding the powdered or granulated ingredients into the tablet press machine, which compresses the material into the desired shape and size using punches and dies. The process may also involve the use of excipients, such as binders, lubricants, and disintegrants, to improve the tablet’s properties.

Tablet & Capsule are the two oral solid dosage forms commonly used, the tablet has a number of advantages.

Advantages of Tablets over other oral dosage forms :

  1. Accurate dosing: Tablets can be manufactured to contain precise amounts of active ingredients, allowing for accurate dosing and consistent therapeutic effects.
  2. Convenient and easy to use: Tablets are small, easy to swallow, and can be taken without the need for any special equipment or administration techniques. They are also easy to transport and store.
  3. Stable and long shelf life: Tablets can be manufactured to be stable and have a long shelf life, ensuring that they remain effective and safe for an extended period.
  4. Customizable: Tablets can be manufactured in different shapes, sizes, and colors, making them easily identifiable and customizable for patient preference.
  5. Protection of active ingredients: Tablets can protect active ingredients from degradation and moisture, preserving their potency and efficacy.
  6. Cost-effective: Tablets are relatively cost-effective to manufacture than the other formulations, making them an affordable option for patients and healthcare providers.

In short, tablets are a convenient, Reliable and effective dosage form that offer several advantages over the other forms of medication.

Tablets having the best-combined properties of chemical, mechanical and microbiologic stability of all the oral dosage forms.

Tablet Compression Process :

The main aim of design and manufacture of compressed tablet is to deliver orally the correct amount of drug in the proper form at or over the proper time and in desired location and to have its chemical protected to that point.

In-Process Quality checks during Tablet compression :

During compression of tablets, in-process tests are routinely performing to monitor the process for Appearance of Tablets, Tablet weight, Weight variation of Tablets , Hardness, Thickness, Disintegration Test and friability,

Tablet Compression Machines :

Tablets are made by compressing a formulation containing a drug or drugs with excipients on stamping machines called Tablet Presses or Tablet compression machine.

Tablet compression machine containing below Basic components :

Hopper : Holding the granules and feeding granules to be compressed.

Feeder : Feeding mechanism for moving granules from hopper and help to fill the die bore during compression run.

Punches :  For compressing the granules within the dies.

Dies : Dies defines size and shape of the Tablet.

Cam Tracks : For guiding the movement of the punches.(Upper and Lower punches)

Tablet Presses are also termed as Rotary Tablet Press because the turret of the machine that holds the upper punches, dies and lower punches in place and that rotates and circular motion.

As the turret rotates, the punches are guided up and down by fixed cam tracks, which control the sequence of filling, weight adjustment, pull down, pre-compression, main compression and ejection.

Tablet Compression Cycle :

This sequence of filling, weight adjustment, pull down, pre-compression, main compression and ejection called as ‘Compression Cycle’.

Tablet Compression Machine Tablet Compression Cycle     

Fill Position (Die Fill) :

At the fill position, the lower punch is pulled down by the fill cam as the die is passing under the feed frame. The pulling down of the lower punch creates a void space in the die bore. The effect of void space and with the help of or movement of feed frame/Feeder allows  powder/granules to flow into the die bore either a Gravity feeder or Rotary feeder . As the die continues its pass under the feed frame, the powder/granules continues to flow into the bore under the force of gravity.

The position of the fill cam remains fixed for the entire production run and can only be readjusted or changed manually. The fill cam at a fixed position allows each die to be filled with the same amount of powder. After the die bore has been filled after that lower punch is transferred to the weight-adjustment cam.

 

What is mean by Gravity Feeder ?

In gravity feeder material flows in the die bore through the gravitational force i.e. in short Material flows without a mechanical aid.

Gravity Feeder - For Compression Machine

Gravity Feeder – For Compression Machine

What is mean by Force/Rotary Feeder ?

In force feeder material is actively pushed over the die by rotating paddles i.e. in short mechanical aids are using for pushing the powder in die bore.

 

Force Feeder-For Compression Machine

Force Feeder-For Compression Machine

 Weight – Adjustment Position : 

The weight-adjustment cam raises the lower punch, which pushes excess powder out of the filled die as per the setting of weight adjustment cam. After the die leaves the area of the feed frame, a spring-loaded, knife-edged blade scrapes the surface of the die and removes any excess powder.

The highest vertical position reached by the weight adjustment cam regulates the amount of powder expelled and the amount of powder remaining in the die, thus determining the final weight of the tablet.

Increasing the highest upward position of this cam will come out powder from die, resulting the tablet weight will be reduced i.e. Thin tablets will be formed. likewise, decreasing the cam’s highest downward position more powder will fill in die bore, resulting  tablets weight will be increased i.e. Thick tablets will be formed.

In manual Presses, a manual handwheel controls the position of the weight adjustment cam, on automated presses a computer controlled feedback loop sets available for Weight adjustment.

Pull – Down Position : 

Newer press models have a pull-down position, which allows the lower punch to be pulled down slightly so that the top of the powder column in the die bore is below the surface of the die table. Simultaneously, the upper punch is lowered by the lowering segment of the upper cam track.

The lowering of the powder column prevents any powder from being blown out of the die as the upper punch enters the die bore, will prevents variations in tablet weight and after that immediately upper punch enters the die, precompression begins.

Pre-compression Position :

During precompression, loose powder is consolidated in the die by the removal of any air entrapped in the powder column and by the physical orientation of the powder particles. The ‘Tablet’ formed at this step is now ready for main compression.

 Main Compression Position :

The main compression step gives a tablet its final characteristics. The final tablet thickness is determined by the distance between the punch rollers, which determines the distance between punch tips. In new presses the main compression position also can be monitored for automatic thickness control.

Tablet Ejection and Take-off Position :

Before reaching the full ejection position, the upper punch is lifted out of the die bore with the help of Cam track, while the lower punch is being pushed up by the ejection cam, thereby pushing the tablet out of the die. At the full ejection position, a tablet take-off bar located above the die table, guides the tablet off  through the exit chute to Collection bin and Tablets are collecting in Tablet collection bin/Container/Drum.

Note : Toolings, which conforms the standard specifications, can eliminate many production problems.

What are the Types of Tablet Compression machine ?

  1. Single Rotary Machine
  2. Double/Multi Rotary machine

What is mean by Single Rotary Machine ?

Compression machines are designed to accomplish one compression cycle while the turret makes a single revolution. These types of presses require hoppers, feed frames, cam tracks and compression rolls are one in number which is called Single Rotary Machine.

What is Mean by Double/Multi Rotary machine ?

Compression machines are designed to accomplish more than one compression cycle while the turret makes a single revolution. These types of presses require additional hoppers, feed frames, cam tracks and compression rolls which is called Double/Multi Rotary Machine.

Major advancement in the tablet industry have occurred with new models of rotary tablet presses there speed has increased; a Precompression stage has been added; and, in some presses computer technology automatically adjusts the powder fill mechanism for lower punches to maintain the proper tablet weight.

 A Tablet Compression machine’s output is regulated by three basic characteristics of its design :

Number of tooling sets,

Number of Compression Stations

Rotational speed of the press.

Tablet Categories :

Producing a Tablet with a unique design often increases a product’s recognition among consumer. Although tablets can be produced in variety of shapes and sizes, The limiting factors are usually related to characteristics of the Press and the Tooling used to produce the tablets

 Round Tablets :

Round Tablets include primarily Convex and Flat-faced tablets. Frequently people use the term ‘concave’ to describe both the surface of punch and the surface of tablet produced. Technically, the punch surface is usually ‘concave’ and surface of the tablet produce is ‘convex’.

Concave tablets can further categorized according to their cup depth as :

  • Shallow Concave,
  • Standard Concave,
  • Deep Concave,
  • Extra Deep Concave and
  • Modified Ball Concave.

Flat-faced tablets can further categorized as :

  • Flat-faced Plain,
  • Flat-faced Bevel Edged and
  • Flat-faced Radius Edged.

 Shaped Tablets :

Tablets that have geometric configuration other than round shape are ‘Shaped Tablets’.

Shaped Tablets categorized as :

  • Capsule shaped,
  • Oval Shaped,
  • Oblong Shaped,
  • Hexagonal Shaped,
  • Rectangular Shaped etc.

General Terminology uses for Tablets :

Tablet Face :- The area within the tablet’s periphery.

Band :- The area between the opposing cup profiles. The die wall forms the tablet band.

Cup :- The depression or concavity at the end of a punch tip.

Cup Depth :- The distance from the tablet’s band to the highest point of apex of the cup’s radius.

Land :- A narrow plane perpendicular to the tablet’s band, which creates a junction between the band and the cup.

Tablet Thickness :- The combined height of the two cups and the band determines the total thickness of a tablet.

Tablet Identification :- Any logo / company name / product name / code applied on tablet’s face by means of debossing or embossing.

Debossed :- A tablet identification that is depressed on the tablet’s surface, forming a groove.

Embossed :- The projection of tablet identification above the tablet’s surface.

Tablet Printing :- In this method identification is mechanically printed on the tablet’s surface with liquid ink.

What is mean by Debossing on Tablet ?

A Tablet identification that is depressed on the tablet’s surface by the punch tip forming a groove called as debossing.

What is mean by Embossing on Tablet ?

The projection of tablet identification on the tablet’s surface called embossing.

Following factors can affect the optimal design of tablet identification :

  • Coating of Tablet
  • Breakline or Score
  • Compressibility of formulation
  • Moisture in formulation
  • Area available on tablet surface
  • Complexity of the identification
  • Location of the identification

Tablet Tooling :

The function of tablet tooling is to produce tablets with predetermined physical characteristics, such as shape, thickness, weight and hardness. To achieve this, the Die cavity is filled with granules to a depth that is predetermined by the position of the Lower Punch.

The Lower Punch’s position determines the amount of granules used in each tablet. The Upper Punch is then guided into the Die bore and force is applied to both the punch heads with the compression rollers, thereby compressing the material into a Tablet.

The Tablet’s Shape is determined by the configuration of the Die bore and the Punch tip. The tablet’s Thickness and Hardness are determined by the amount of compression force applied to the punch heads, whereas its weight is determined by the amount of granulation loaded into the die before compression.

Comparison of Shaped and Round Tooling :

Punches and Dies used to manufacture round tablets are called “round tooling” and Punches and Dies used to manufacture shaped tablets are called “shaped tooling”.

After the designer has determined the geometric configuration of a tablet, the desired configuration is reproduced in the punch tips and die bores.

The upper punch for a shaped tablet has a device called a key that is inserted into a slot in the barrel and projects above the barrel’s surface. The key prevents the punch from rotating as it is lifted vertically from the die bore so that the punch can re-enter the die bore at the proper alignment. Because round configurations are usually unaffected by rotation of the upper punch, round punches rarely require a key.

However, if a round lower punch is embossed, a key is sometimes used to prevent punch rotation and possible distortion of the embossing during tablet ejection.

Tooling dimensions which affects on Tablet Manufacturing :

The proper interlinkage within tools and the presses on which Tablet Toolings  are installed is the crux of determining the appropriate dimensions and tolerances for tablet tooling.

Working Length :

It is the length from head flat to bottom of cup depth. Working length is the most critical dimension of a punch because variation in working length of lower punches translates directly into variations in tablet weight. The effect of the tolerance range for working length can be as little as a fraction of a percentage.

Major variation in working length of the punches will cause proportionate variations in tablet thickness during compression run.

During measuring the working length of a new punch using a pointed indicator tip, it should be positioned as closely to the center of the punch cup as possible. If embossing or Breakline is present, the indicator tip should positioned between the embossing characters or besides the Breakline; the working length for each punch should be measured at the same location on the individual punch cups.

Cup Depth and Overall Length :

Cup depth is rarely measured directly because different indicator tips are required to measure it. Variation in cup depth has very little effect on tablet weight or hardness. The effect is most pronounced on shallow concave and flat-faced bevel-edged (FFBE) tooling. The variation in overall length within the set is more important than the average value.

Head Thickness :

On many tablet presses, the thickness of lower punch heads plays an important role in maintaining consistent tablet weight and limiting the upward flight of the punches at the point of final weight adjustment and tablet ejection.

Head Flat Diameter :

The diameter of the punch head flat and the turret speed of the press determine the amount of time the tablet material undergoes maximum compression. The time of maximum compression called as dwell time, which directly affects the tablet hardness.

 Punch Tip :

Tip of the punch guides the punch in the die and provides a tight fit between the punch and die to prevent the loss of granules from the die bore.

Punch and Die Maintenance :

Proper maintenance is the most important factor in maximizing the life of Punches and Dies. Maintaining tooling also minimizes many compression problems such as variation in weight, variation in thickness, Picking, sticking, capping, Laminations etc.

Handling of Punches :

The most important factor in tooling maintenance is appreciating the delicate nature of punch tips. Although a punch tip is designed to withstand several tons of pressure in a press, it is very easily damaged by the slightest contact with a hard metal surfaces.

Therefore, a punch tip should never come in contact with :

Any part of another punch, whether on the press/ bench or in storage,

Any part of press, any metal tools or equipment such as a polishing unit, storage container etc.,

Successful Run of Tablet Press :

A successful run can be defined as an operation of the tablet press which produces excellent tablets with minimum downtime without continued tablet problems (such as picking, capping, weight variation & hardness variation but not limited to) and little to no wear to mechanical components of the press and press tooling.

A tablet press is one of the most complex machines used in the manufacturing environments. Worldwide, more than 15 different companies make tablet presses. All Tablet presses operate in the same basic way with only a few difference innovative exceptions.

Many granulation problems can be solved on the press, but they can be created on the press as well.

The first step in obtaining a successful run is performing proper cleaning and setup. If cleaning and setup are conducted completely and correctly, two-third of that successful run is accomplished.

 Job Responsibilities in Tablet Compression sections :

Tablet Compression machine Operator :

  • Daily cleaning and sanitization of Tablet compression area by using disinfectant solution.
  • Machine cleaning as per SOP during product and batch changeover.
  • Machine setting as per SOP.
  • Safely operating the machine with minimum rejections and maximum output with maintaining quality standards.
  • Performing In process checks and recording them on BMR.
  • Operating and down time recording on machine log.
  • Checking cleanliness of empty containers & fixing of status label with signature.
  • In process checking of  compressed tablets and recording on label and BMR.
  • Compressed tablet container pellet transfer to tablet storage area.
  • Machine maintenance as per scheduled time.

Production Officer/Executive :

  • Work allocation in the section
  • Supervision of Tablet compression area and co-ordination with Quality control, Maintenance, Coating & Packing for smooth production planning
  • Line clearance during product changeover or batch changeover.
  • Cleanliness of area and proper housekeeping.
  • Checking of machine setup and certification as per BMR
  • Inprocess  checks and recording on BMR.
  • Calibration of balances and other equipments.
  • Adherence to cGMP and SOP.
  • To maintain discipline in Department.
  • Submit Daily Production Report and completed BMR to Production executive or Department Head.

Department Head :

  • To complete the production schedule as per accepted plan with quality and optimum utilization of resources.
  • Co-ordination with other Department & Units.
  • Daily and weekly Scheduling of work.
  • Planning of Manpower requirement.
  • Procurement of new equipment’s, Instruments, change parts and spares.
  • Checking of documents and updation of SOPs with respect to the current regulations and practices.
  • Review of preventive maintenance schedule.
  • Conducting training program for Machine Engineer, Officers & Workmen.
  • To under take the Departmental activities in absence of Executives.

Troubleshooting During Tablet Compression :

Troubleshooting Tooling Problems :

Tooling problem could be easily avoided by using the Tablet compression machine running correctly.

If not checked properly, damage could result in the cost of a new set of tools or even major repairs to Tablet compression machine.

Following are most common tooling related problems during production :

Tooling Problem Cause Corrective action Comments
Punch tip cracked & broken away across the face / along bevel angle & tip face / along angle between breakline & tip face / along embossing Excessive hardness for application. Excessive pressure by compression rollers None. Discard tool and consult tooling manufacturer.     Check if pressures can be released. Tools should always be run at the minimum pressure advised by vendor.
Wear pattern in die bore Continuous pressure at compression area Check that correct steel was chosen. Consult tooling manufacturer. Possibly compress tablets at different areas and reverse die when one end is worn. This can lead to punch tightness and ejection problem.
Edge of punch tip damaged outside the press Mishandling of tooling. Damage during setting Carefully remove the damage by polishing if possible, otherwise Discard tool. Exercise extreme care should be taken during handling of tooling’s. The punch tips are fragile.
Damage on punches similar to embossing of opposite punch Contact between upper and lower punches in the press Carefully remove the damage by polishing if possible otherwise Discard tool. Do not run the press without granules.
Worn of punch head flat Excessive pressure Worn / damaged pressure roller foreign matter between roller and punch head Reduce pressure. Repair / replace pressure roller. Thoroughly clean the press. This may lead to serious wear and damage to the tooling’s and the press.
Punch barrel has snapped in the press Upper punch being prevented from entering the die due to any tip damage; the head then strikes part of the punch guide system & breaks the barrel. Excessive tightness. Discard the punch. Monitor condition of tooling at all times to avoid tightness and excessive pressure. With unenclosed pressure, the broken part may be ejected from the press with considerable force, endangering personnel and equipment.

 

Troubleshooting Production/Process Problems :

Problems encountered during tablet production may be caused by

Deficiencies in the granules,

Setting of the tablet press

Many times, a deficiency in one component leads to improper functioning of and / or damage to the other components

Following are most common  related problems during production :

Problem Cause Remedy
Nonuniform tablet weight a)   Inconsistent punch flight Check for free movement of punches.Check that no excessive Press vibration.Ensure proper setting of weight adjustment ramp.Check proper setting of anti turning strips.
b) Granules lost or gained after filling of die Check proper setting of scrapper.Ensure no leakage from recirculation band.Check proper setting of dust extraction nozzle.
c)   Feeders chocked/Stucked Ensure proper setting of hopper spout.Check that no bridging of granules in hopper.Check for use of proper size of fill cam.Check for no excessive recirculation of granules.
d)   Dies not filling Reduce Press speed.Check correct speed of feeder paddle.Check for proper shape of feeder paddle.
e)   Lower punch pulled before filling of die Check for sufficient recirculation of granules.Check for proper setting of recirculation scrapper.
f)    Poor scrapping Ensure no bent or worn of the scrapper blade.
Nonuniform tablet weight g)   Nonuniform punch length Ensure that the working length of all punches is within ± 0.010 inch of standard specification.
h)   Projection die above die table Clean die pockets.Check for correct die dimension.
i)    Auto weight control not working Check for correct operation & settings of auto weight control system.
j)    Wide variation in thickness of lower punch heads Ensure that head thickness of all lower punches is within ± 0.01 inch of standard specification.
Nonuniform tablet thickness a)   Nonuniform tablet weight See above given Cause and Remedies.
b)   Bouncing of pressure rollers Check proper setting of overload release.Release pressure or reduce weight.Check for free movement of rollers.Check for any air trapping in hydraulic overload system.Check that pivot pins of rollers not worn.
c)   Nonuniform punch length Ensure that the working length of all punches is within ± 0.010 inch of standard specification.
Black spots on tablets a)   Contamination of Extraneous matter  Clean press more frequently.Check for Excessive or wrong press lubrication.Check for use of proper dust caps.Check for rubbing of feeder components.
Nonuniform tablet friability a)   Nonuniform tablet weight and thickness See above given Cause and Remedies.
b)   Unequal distribution of granules in die Check that no Separation of granules in hopper.Check that no excessive recirculation of granules.
c)   Low moisture content Add moisture to aid bonding. Procedure to be followed as per Available SOP /QMS for the same.
Nonuniform tablet friability d)   Granules Segregation in hopper Reduce variation in particle size.Reduce machine speed.
Excessive vibration of press a)   Worn drive belt Check drive belt & replace if necessary.
b)   Nonuniform punch length Ensure that the working length of all punches as per the  standard specification.
c)   Press operating at maximum density point of granules Increase tablet thickness by releasing pressure.Reduce tablet weight within limits.
d)   High ejection pressure Check for worn of ejection cam.Add more lubricants in granules.Use tapered dies.
e)   Improper pressure release setting Increase pressure to the tooling’s limit.
Excessive loss of granules a)   Improper setting of feeder Set the feeder correctly.Check that no worn of base of the feeder.
b)   Improper setting of recirculation band Check that no gap between band’s bottom and die table.Ensure proper pressure on hold-down spring of the band.
c)   Insufficient scrapping Check that no any bent or damage to the scraper plate.Check the gap between turret surface and Scrapper plate.
d)   Loss of granules at compression stage Check that compression not occurring too high in the die.Ensure the setting of exhaust nozzle or excessive suction.Punch penetration need to check.
e) Loss of granules between lower punch & die Check if there excessive clearance between lower punch & die bore.Ensure for no excessive fines in granules.
Capping and Lamination a)   Air entrapment Compress the granules upside position in die.Reduce speed of the press.Use pre-compression system.Reduce fines in the granules.Reduce cup depth of punches.Use tapered dies.Ensure for correct clearance between  punch & die.
b)   Excessive pressure Reduce tablet weight / increase tablet thickness within allowable limits.Adjust pressure.
c)   Ring formation in dies Reverse dies.Compress the granules upside position in die.
d)   Rapid expansion of tablet after ejection Use Tapered dies.
e)   Weak granulation Increase quantity of binder. Use stronger binder.  Procedure to be followed as per Available SOP /QMS for the same.
f)    Excessively dry granulation Increase level of lubricant. Procedure to be followed as per Available SOP /QMS for the same.
g)   Excessive lubrication of granules Decrease level of lubricants. Procedure to be followed as per Available SOP /QMS for the same.
h)   Punch tips worn or burred Polish punch tips. Replace punches.
i)    Lower punch set too low at eject Set lower punch tip flush with top of die at ejection.
j)    Ejection plate set too high Adjust setting of ejection plate.
Picking & sticking a)   Excessive moisture Check moisture content of granules.Check humidity in compression cubicle.
b)   Punch face condition Polish punch face if pits or improper draft observed on punch face.Try chrome plated punches.
c)   Insufficient compaction force Increase tablet weight / reduce tablet thickness within allowable limits.
d)   Inadequate lubrication of granules Check and/or adjust level of lubricant.
e)   Poor embossing design Redesign embossing.
Extraneous matter on tablets a)   Contamination of grease / oil Avoid excessive lubrication of upper punches.Fit dust cups/Bellows to upper punches.Check oil seal on upper punch guides.
b)   Contamination from machine components Check, clean & reset machine components correctly (chutes, feed hoppers, cams, paddles, scrapper, ejection plate etc.)
Mottling a)   High moisture content of granules Redry the granules. Procedure to be followed as per Available SOP /QMS for the same.
b)   Oversized granule particles Reduce particle size. Procedure to be followed as per Available SOP /QMS for the same.
Chipping a)   Worn punch tips or dies Polish punch tips. Replace punches / dies.
b)   Burr on punch tips Polish punch tips. Replace punches / dies.
Splitting of layered tablets a)   Excessive pressure  Decrease pressure. Check the precompression roller setting. Check for the punch penetration setting.
b)   Excessive lubrication of granules Reduce amount of lubricants. Procedure to be followed as per Available SOP /QMS for the same.

 

Safety Precautions during Tablet Compression :

Personal Safety :

Precautions should be taken with respect to personal protection are as below :

  • Use of personal protective equipment’s such as – Snood, Hand gloves, Shoes, Goggles, Earmuff, 3M mask, Respirator, Face shield etc. as per the requirement.
  • Concentration of Operator & Officer on work is utmost important. They should always alert and near the machine for any abnormality.
    The person working on the machine should be physically fit.
  • Continuous working of a person on the same machine should be avoided because it creates fatigue and divides the person’s attention.
  • Unsafe acts should be avoided like – climbing over the machine / touching moving parts of the machine / maintenance of the machine without electrical isolation / leaving stacker in upward direction for longer time / oil spillage / congested area / violation of SOP & safety instructions.
  • Never go for manual Lubrication or maintenance of running machine.
  • Avoid improper communication while working two or more persons working on machine simultaneously during machine cleaning / changeover / maintenance.
  • Never by-pass any interlock of the machine.
  • Use Earthing & Bonding wherever there is static charge generation.

Product Safety :

Product safety is most important as a patient is consuming it, Precautions should be taken with respect to product safety are as below :

  • Handling of product should be done in ‘Closed condition’ as far as possible.
  • Oil leakage problem in any machine should be rectified immediately.
  • Proper cleaning of equipment’s to be done as per SOP.
  • Minimize rubbing of machine parts, which are coming in contact with product.
  • Avoid spillage of product during handling.
  • Never ever IN process checks should be bypassed

Machine safety :

Precautions should be taken with respect to Machine safety are as below :

  • Precautions, to be taken to avoid damage / major breakdown of the machine.
  • Rotation directions of the machine must be checked after every electrical maintenance.
  • Preventive maintenance and Lubrication of the machine should be done regularly as per schedule.
  • Setting of the machine should be done as per SOP and proper toolings should be on the machine.
  • Operation of machine beyond its capacity must be avoided.

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