Author: chandrasekhar Panda
Inspection procedure for Capsule :
|After line clearance, transfer the filled capsule in SS tray or on the inspection table layered with HDPE polythene bag and spread the capsules on inspection table.|
|Capsule should be visually checked for various defects (Dented, telescopic, Poor printing or no printing on capsules, Poor locking Quality, Improper polishing, Double caps Empty capsule etc) & Rejected capsules should be kept in Polythene bag containing online rejection label as per SOP of “Procedure for Status Labelling” .|
|Collect the good capsules in HDPE container lined with double polythene bags and weigh and label it properly as per Batch Manufacturing record|
|Summary of rejection quantity for various defect of capsule shall be recorded as per provision given in Batch Manufacturing record|
|Some Picture of various defect of capsule given below for clarity regarding distinguish the different types defect.|
An autoclave is a sterilization device that is widely used in in hospitals, Pharmaceutical industries and laboratories. Sterilization is critical within the pharmaceutical and medical industries.
How do Autoclave works :
An autoclave is a device that works on the principle of moist heat sterilisation, wherein saturated steam is generated under pressure in order to kill microorganisms such as bacteria, viruses, and even heat-resistant endospores from various types of instruments. This is done by heating the instruments within the device to temperatures surpassing the boiling point of water.
This process is also embodied by gas laws, which basically states that the higher the pressure is within the device, the higher the temperature increases. In other words, pressure and temperature are directly proportional to each other.
It is also important to note that it is the temperature that kills the microorganisms, not pressure. Rather, higher pressures are capable of increasing the boiling point of water, which thus increases the temperature of sterilization. High pressure also helps heat to rapidly spread within the material.
Autoclaves typically yield a temperature of about 121 degrees Celsius, taking about 15-20 minutes to complete the sterilization process. However, autoclave cycles may be adjusted accordingly by the working technician.
Autoclaves are grounded on three factors, namely: pressure, temperature, and time. These three factors all work together to create saturated steam, within a particular time frame, that can kill all signs of microbial life, whether they are in vegetative or spore form.
What is The Operating Procedure of Autoclave :
1). Check if there are previous instruments, Glass, stainless steel, cultures etc contained within the chamber.
2). Put water in the chamber and make sure it is the right amount.
3). Place the instruments, Glass, stainless steel, cultures etc inside the chamber which are required to be sterilized.
4). Close the lid and tighten the screws then switch on the electric heater.
5). Adjust the safety valves to maintain the required pressure level within the chamber.
6). Once the water within the chamber begins to boil, the air-water mixture can escape through the discharge tube in order to displace all the air inside. Complete displacement is evident when no more water bubbles come out from the pipe.
7). Close the drainage pipe and let the steam reach the desired level.
8). Once the pressure level has been reached, blow the whistle to remove all the excess pressure within the chamber.
9). Let the autoclave run for the set time period after the whistle.
10). Switch off the electric heater and let the autoclave cool until the pressure within the chamber has lowered down to the atmospheric pressure.
11). Open the discharge pipe to allow air from outside the autoclave to enter.
12). Open the lid and remove the instruments from the chamber.
The Stages of Autoclave Sterilization :
The sterilization process includes different phases
- Purge Phase : During this phase steam displaces air within the autoclave chamber and both temperature and pressure begin to increase
- Sterilization Phase : The exhaust remains closed, allowing the temperature and press to rapidly rise to the desired values. It is during this phase that autoclaves harsh conditions destroy bacteria, spores and other pathogens.
- Exhaust Phase : Pressure is released from chamber, but temperature remain high. Operator or microbiologist should take care when removing hot contents from autoclave.
Autoclave Compatible and Incompatible Materials
|Compatible Materials||Incompatible Materials|
|Biological cultures and stocks||Materials containing solvents, volatile or corrosive, or flammable chemicals|
|Culture dishes and related materials||Material contaminated with chemotherapeutic agents or cytotoxic drugs|
|Contaminated solid items (i.e. pipette tips, gloves, Petri dishes, etc.)||Material containing Bleach*|
|Discarded live (including attenuated) viruses/vaccines||Carcinogens or mutagens (i.e. ethidium bromide)|
|Polypropylene (PP) and polycarbonate (PC) plastics||Phenol and Trizol|
|Borosilicate glass||Polystyrene (PS), polyethylene (PE), and high-density polyethylene (HDPE) plastics|
|Stainless steel||Houshold glassware|
What is Equipment usage logbook :
The purpose of this Document is for Recording the usage, cleaning and maintenance activity of Equipment in a chronological order, with done by, checked and reviewed by signature.
Separate Equipment usage log shall be issued for each process Equipment and Issued Equipment usage log book shall be used for execution.
Equipment Logbook shall be the person who has done or perform the activity and shall be checked by another person for correctness.
- All equipment user logs shall be under the control of quality assurance department.
- The equipment user log shall contain the following details.
- Equipment information
- The first page of all equipment log shall contain the equipment information i.e., equipment name, equipment number, model and month.
- Equipment user log issued from quality assurance department on request of production.
- Equipment user log format.
- Equipment user log shall contain the details of user log (Annexure-1)
- Quality assurance department shall issue the equipment user log for equipment on rising of requisition slips fore equipment user log duly approved by In-charge /executive.
- The respective section In-charge shall verify the equipment user log.
- The executive Quality Assurance department shall review all the log for every 15 days. In case of any discrepancy, the same should be brought to the notice of the respective department In-charge for corrective action.
- The completed user log shall be returned to QA department.
- Document controller shall store the completed log.
Entries in user log :
- All the entries shall be made with black ballpoint pen.
- If any column is not applicable, enter NA in the respective column.
- Time shall be entered as hours round the clock. For ex: 12 AM shall be entered as 00.00 hour and 1:00 PM shall be entered as 13:00hour.
- Any events related to the instrument shall be entered in remarks column otherwise enter “Nil”.
- The respective department operator /executive shall fill all the columns in the user log before starting the procedure / analysis except end time and remarks column. End time and remarks column shall be filled after the completion of activity.
Correction of wrong entries:
For any error during entry, the following process followed and In case, any wrong entry occurs, strike it out with a single line.
Clearly write the correct entry near the wrong entry.
Sign and put the date on which the correction was made.
If an entire line has to be deleted, strike it out with a single line (horizontal/vertical).
Write a note explaining the reason for deletion with sign and date.
The section-in-charge shall verify and counter sign on the same.
Annex – 1 Equipment Usage Logbook
The fish bone diagram or Ishikawa diagram is a cause-and-effect diagram that helps to identify many possible causes for an problem and it can be used as a Investigation tool.
It can be used in case of any Deviation, Market Compliant, Out of specification to identify the possible root cause for the problem.
The diagram looks just like a fish’s skeleton with the problem at its head and the causes for the problem feeding into the spine. Once all the causes that underlie the problem have been identified, the investigator can start looking for solutions to ensure that the problem doesn’t become a recurring one.
Fish bone diagrams help us to determine the variables that may enter the equation. They allow us to make our plans so that we know how to deal with them in such a way that the quality of our final product is still up to standard and without significant variation.
Ishikawa diagrams were popularized in the 1960s by Kaoru Ishikawa , who pioneered quality management processes in the Kawasaki shipyards, and in the process became one of the founding fathers of modern management. In the 1920s it was seen as an important quality control tool.
Hi in this Topic I have provided some questions and answers of Disintegration Test Apparatus which will be useful to freshers as well as experience personnel to gain some knowledge. Always i have tried to provide good and quality contents for my viewers or readers or followers. So pl read and provide your feedback
For Dissolution Test Apparatus interview questions and answers please refer https://pharmaceuticalupdates.com/2021/05/25/dissolution-test-most-important-interview-questions-and-answers/
Hi this is Chandrasekhar Panda and welcome to all my readers and followers. As you know that previously i have updated some interview questions and answers regarding dissolution Test. Always i have tried to provide good contains for my readers and i hope this topic will be useful to the persons working in Quality control and Quality Assurance department to gain good knowledge on dissolution Test Apparatus.
You can read the Dissolution test Apparatus Questions and Answers
So thinking about “How to open a medical store”? Let me tell you this, the pharmacy business is an evergreen business in India that is not affected by economic cycles or even in pandemic situation. So, if one has minimal capital investment and space, the pharmacy store is ideal for many businessmen across India. It will be easy if you are having experience in medical store and Hospital as a Pharmacist.
Q. Who can start a medical shop?
Ans- Anyone who has a Pharmacy Licence is eligible to open a medical store. For becoming a qualified pharmacist you need to acquire a Diploma in pharmacy (D.Pharm) or degree of B. Pharm or M. Pharm.
Q. Is chemist shop a profitable business?
Ans- Any chemist business or medical store is profitable just like the pharmacy business. Most prescribed drug-related businesses are incurring good profits in the market. Even OTC (over-the-counter) drugs or patent medicine store is decently profitable.
Q. How much is needed to open a medical store?
Ans- To open a medical store in the suburbs a minimum of 3 to 4 lakh rupees is needed. While to open the same in a metropolitan city would easily cost you around 7-8 lakh rupees. You could either be a wholesaler or a specific hoarder. Small businesses can easily apply to avail business loan for medical store.
Q. What are the requirements to open a medical shop?
Ans- To open a medical store you will need the following-
- Rental Agreement/Ownership Proof
- Premises proof ranging at least 10 square meters
- If clubbed into retail then a minimum of 15 square meters is required
Q. What is the procedure to open a medical store?
Ans- Below are some of the mandatory things needed before thinking
about how to open a medical store in India-
- Ownership proof of premises
- Business constitution and registration proof
- Affidavit of non-conviction of proprietor or partners or directors under the Drug and Cosmetics Act of 1940.
- Registered pharmacist affidavit
- Equally competent full time working employees affidavit
Q. Is Cold storage facility required in medical store?
Ans- Yes Most importantly, the store must have a refrigerator on the premises.
This is because, according to the labeling specifications of certain drugs like vaccines, Sera, Insulin Injections, etc., are required to be stored in the refrigerator.
Q. Is Digital system required in medical store for billing?
Do not stick to the old and inefficient method of operating a pharmacy. Do business the smarter way! Managing like billing, inventory, bookkeeping single-handedly or with a bunch of people is challenging and can result in a lot of manual work without the use of technology.
Q. How much profit does a medical store make?
Ans- Any retail medical store profit will range from 5% to 30% every month. Different products will incur different types of margins like-
- OTC (over-the-counter) medicines
- Branded Prescription products
- Generic Medicines
- Trapped Products
- Brand-specific discounted items
Q. Can Doctor run a pharmacy?
Ans- No, doctors aren’t officially allowed to run a pharmacy shop based on Medical ethics. Any of the Drug License for the hospital is allotted in the name of a Pharmacist and not the Doctor or even the Hospitals owner!
Q. How many years is a Diploma in Pharmacy?
Ans- Diploma in Pharmacy is a 2 years full-time course. It consists of the following subjects-
- Human Physiology
- Therapeutic Compounds & drugs in use
- Their pharmacology & formulations
- Basics on drug store management
- Pharma Jurisprudence
Q. Is a pharmacist a medical professional?
Ans- Pharmacists, in general, are extremely trained health professionals who specialise in a comprehensive spectrum of services like-
- Conducting Health And Wellness Testing
- Managing Chronic Diseases
- Performing Medication Management
- Administering Immunizations
Q. Can I open a medical store after D Pharma?
Ans- The official requirement to open a medical store in India is becoming a registered pharmacist. So after the completion of your D.Pharm, you have to register yourself at your state pharmacy council and obtain official certification that’ll take around 45 days after the registration process, and then you can start a medical shop.
Firstly, avoid renting/owning the shop where there are already Multiple medical stores to avoid unnecessary competition and if required try to search Rural areas to set up your business.
It will be better if you can always network with a doctor/Hospital so that you can tie-up with them.
Before set up your own medical store it will be better to gain some experience by working in any medical store or Hospital or under any doctors
For betterment you can refer the CIMS Drug books or 1 mg.com or Netmeds to know the name of drugs, their substitutes, dosage, indication and uses etc. You can use the APP or can download the same and can read to gain some better knowledge.
Use SMS alert system i.e automatically patient can get the SMS to refill their medicines and record the patients history in your data bank and if required you can think for Home delivery of medicines at doorstep.
UV-Visible spectroscopy is a mature and well-established analytical technique used extensively in many industry sectors including Environmental Analysis, Pharmaceutical Testing, Food and Beverage Production etc.
Spectroscopy is the measurement and interpretation of electromagnetic radiation absorbed or emitted when the molecules or atoms or ions of a sample moves from one energy state to another energy state.
UV spectroscopy is type of absorption spectroscopy in which light of ultra-violet region (200-400 nm) is absorbed by the molecule which results in the excitation of the electrons from the ground state to higher energy state.
UV-Visible Spectroscopy is based on the Lambert-Beer principle which states that the absorbance of a solution (A) is directly proportional to its path length (l) and its concentration (c) when the wavelength of the incidence light remains fixed.
Basically, spectroscopy is related to the interaction of light with matter.
As light is absorbed by matter, the result is an increase in the energy content of the atoms or molecules.
When ultraviolet radiations are absorbed, this results in the excitation of the electrons from the ground state towards a higher energy state.
Molecules containing π-electrons or non-bonding electrons (n-electrons) can absorb energy in the form of ultraviolet light to excite these electrons to higher anti-bonding molecular orbitals.
The more easily excited the electrons, the longer the wavelength of light it can absorb.
The absorption of ultraviolet light by a chemical compound will produce a distinct spectrum which aids in the identification of the compound.
If there is no absorption of the light passing through the solution, the transmittance is 100%.
The UV-Visible Spectrophotometer is the analytical instrument used for the UV-Vis spectroscopic analysis. Spectrophotometers are available in different configurations however most can be categorized into either single beam, split beam or double beam types depending on the design of their optical system. Such types of instrument comprise the following components in their constructions:
1. Light Source :
- Tungsten filament lamps and Hydrogen-Deuterium lamps are most widely used and suitable light source as they cover the whole UV region.
- Tungsten filament lamps are rich in red radiations; more specifically they emit the radiations of 375 nm, while the intensity of Hydrogen-Deuterium lamps falls below 375 nm.
2. Monochromator :
- Monochromators generally is composed of prisms and slits.
- Most of the spectrophotometers are double beam spectrophotometers.
- The radiation emitted from the primary source is dispersed with the help of rotating prisms.
- The various wavelengths of the light source which are separated by the prism are then selected by the slits such the rotation of the prism results in a series of continuously increasing wavelength to pass through the slits for recording purpose.
3. Cell Compartment :
- One of the two divided beams is passed through the sample solution and second beam is passé through the reference solution.
- Both sample and reference solution are contained in the cells.
- These cells are made of either silica or quartz. Glass can’t be used for the cells as it also absorbs light in the UV region.
4. Detector :
- Generally two photocells serve the purpose of detector in UV spectroscopy.
- One of the photocell receives the beam from sample cell and second detector receives the beam from the reference.
- The intensity of the radiation from the reference cell is stronger than the beam of sample cell.
5. Signal Processing System :
- Most of the time amplifier is coupled to a pen recorder which is connected to the computer.
- Computer stores all the data generated and produces the spectrum of the desired compound.
This absorption spectroscopy uses electromagnetic radiation between 190 and 800 nm and is divided into two regions
1. UV (190–400 nm)- Deuterium lamp
2. Visible (400–900 nm) – Tungsten lamp
Because the absorption of UV or visible radiation by a molecule leads to transition among electronic energy levels of the molecule, it is also often called electronic spectroscopy.
UV-Visible Analysis is Suitable For,
1. Analytes that can be dissolved in solvents like water, ethanol and hexane.
2. The analyte need to absorb UV or Visible light.
3. With UV /Vis we can do quantitative measurements a single analyte in solution(or more than one analytes om solution provided that do not interfere with each other).
Not Suitable For,
1. Analytes that have a photochemical reaction at the wavelength range of interest.
2. Partially dissolved, unclear or colloidal samples.
The UV-Visible spectrum shows the absorbance of one or more sample component in the cuvette when we scan through various wavelengths in the UV/Vis region of the electromagnetic spectrum.
System suitability is to prove that system is working perfectly before the analysis on HPLC, GC, TOC analyser or any other system. It is required to done before every sample analysis. HPLC, short for High-performance liquid chromatography is a technique used for separating the components in a mixture.
HPLC chromatographic technique is used in pharmaceutical industries for analysis. System suitability testing limits are acceptance criteria that must met before starting the analysis.
There are some System suitability parameters which can be used to check the system before starting the sample analysis are listed below.
1. Retention time
4. Plate Count
5. Tailing Factor
6. Signal-to-noise ratio
In liquid chromatography and gas chromatography, the retention time, tR, is defined as the time elapsed between the injection of the sample and the appearance of the maximum peak response of the eluted sample zone. tR may be used as a parameter for identification. Chromatographic retention times are characteristic of the compounds they represent but are not unique. Coincidence of retention times of a sample and a reference substance can be used as a partial criterion in construction of an identity profile but may not be sufficient on its own to establish identity. Absolute retention times of a given compound may vary from one chromatogram to the next.
Resolution is a measure for the ratio of the distance of two adjacent peak maxima and their widths. For complex sample mixtures Rs should be determined for the critical pairs of components to characterize their separation.
Resolution is calculated by following formula,
RS = 2(tR2 − tR1) / (W1 + W2)
Where, tR2 and tR1 are retention times of two compounds, W2 and W1 are the corresponding widths at the bases of the peaks obtained by extrapolating the relatively straight sides of the peaks to the baseline.
Replicate injections of a standard preparation are used to demonstrate the system performance when it gets exposed to some specified column usage, environment, and plumbing conditions. Data from five or six replicate injections are used if requirement of relative standard deviation is less than 2%.
Plate Count/ Column Efficiency:
The Column Efficiency is measured by following formula,
N = 16(tR/W)2
Where tR is the retention time of the substance, and W is the peak width at its base, obtained by extrapolating the relatively straight sides of the peak to the baseline. The value of N depends upon the substance being chromatographed as well as the operating conditions, such as the flow rate and temperature of the mobile phase or carrier gas, the quality of the packing, the uniformity of the packing within the column, and, for capillary columns, the thickness of the stationary phase film and the internal diameter and length of the column.
Tailing Factor/Symmetry Factor:
Tailing Factor is calculated by following formula,
AS = W0.05/2f
where W0.05 is the width of the peak at 5% height and f is the distance from the peak maximum to the leading edge of the peak, the distance being measured at a point 5% of the peak height from the baseline.
This parameter is used for the lower-end calculation of the performance of the system.
Noise: It is measured between two specific lines that bracket the baseline.
Signal: It is measured starting from the baseline’s middle and ending to the peak’s top.
Once calculating both these factors, the ratio can be measured by dividing the signal value by the noise value. With this, generally, the noise value has to be reduced using one of the following methods:
- Signal Averaging
- Reagent and Solvent Purity
- Column Flushing and Sample Clean-Up
- Temperature Control
- Additional Pulse Damping and Mixing
The signal-to-noise ratio (S/N) is a useful system suitability parameter. The S/N is calculated as follows:
S/N = 2H/h
where H is the height of the peak measured from the peak apex to a baseline extrapolated over a distance ≥5 times the peak width at its half-height; and h is the difference between the largest and smallest noise values observed over a distance ≥5 times the width at the half-height of the peak and, if possible, situated equally around the peak of interest
System suitability tests must be performed under controlled pressure limit. Monitor the pressure variation throughout the analysis.
Conclusion: The above mentioned system suitability parameters are not must. These parameters and acceptance criteria are performed during the method validation and fixed based on the method development outcome results. But system suitability should meet the acceptance criteria before starting the sample analysis.