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Culture Media preparation in Microbiology Laboratory & its SOP

Culture Media Purpose

Culture Media, To make the culture media for the development of microorganisms in the microbiological test of raw materials, In-process sample & finished products.

Culture Media Scope

This designated SOP is applicable for the preparation of Culture Media in Microbiology Laboratory at XX Pharmaceuticals Limited.

Definitions/Abbreviation:

Culture Media: The Culture media is a liquid or gel designed to support growth of microorganisms or cells or small plants. There are different type of media for growing different type of cells.

There are two major types of growth media: those used for cell culture, which use specific cell types derived from plants or animals, and microbiological culture, which are used for growing microorganisms, such as bacteria or yeast.

Responsibilities:

The roles and responsibilities are as follows:

Officer/Sr. Officer, Microbiology

To follow the instructions of the described procedure accordingly.

Asst. Manager/Manager, Microbiology

Ensure that the procedure is kept up to date.
Ensure right personnel from the section are trained on this specific procedure.
Ensure the media preparation, sterilization, requisition, maintain accurate storage & proper documentation.
To Confirm that this SOP is technically sound and reflects the required working practices as current practices.

Head of Quality Assurance

Approval of SOP
To ensure the overall implementation of the SOP

Procedure

Instructions

Dehydrated media are hygroscopic & are sensitive to light, heat and moisture. They are adversely affected by extreme changes in temperature e.g. hot/ cold cycling temperatures which may occur between day and night laboratory temperatures in winter season.

Condition of Media Preparation:

Take clean & dry flask as per required volume.
Wear appropriate Laboratory garments, gloves and mask.
Wear safety goggles during selection of hazardous media.

Storage Condition of Dehydrated Media:

Mention receipt date on the label when enter into laboratory.
Store as per directions on the label; typically below 25⁰C in a dry area, away from direct sunlight, autoclaves, drying ovens or other heat sources, Where indicated store at (2-8)⁰C.
Check expiry date on the specific label, some media have suggestively shorter shelf life than others.
Use/maintain stock in lot/batch number order. Maintain FIFO [First In First Out], FEFO [First Expiry First Out].
Do not open a new bottle until the previous bottle has been emptied. Ensure date with label on the supplied container when it first opened.
After intended use, ensure the container is tightly closed and store it into the designated storage area.
Collect/procure/order the medium in an appropriate size of container and in a quantity which harmonies to normal use requirements.

A medium in a large container which has been opened many times will deteriorate on storage. Discard the medium if the powder is not free flowing, if the colour has changed or if it appears abnormal in any way.

Temperature of media storage room/facility/area/location should be monitored through min./max. thermometer and limit shall be followed as per the media storage requirements.

List of media having designated storage condition and specific pH limit shall be prepared as per Annexure-II and shall be displayed near media storage facilities.

pH Check:

Check pH of the specific medium before sterilization with calibrated pH meter. If required adjust the pH with the help of 1N or 0.1N NaOH and 1N or 0.1N HCl solutions.

Culture Media Preparation:

Select the media as per specific requirements.
Read the instructions on the label very carefully before preparation of the specific media.
Weigh the media according to the instructions of the manufacturer of the supplied media.
Close the media container tightly just after weighing in order to avoid the moisture acquisition.
Reconstitute the media with purified water and boil it appropriately until entirely dissolve.
Distribute the reconstituted media into clean and dry flask as per requirements.
Cap the flask using cotton plug or screw cap appropriately.
Transfer the media flask into the detest room for use if instructed on the label as “DO NOT AUTOCLAVE” the media.

Sterilization:

Place all prepared media into the autoclave.
Sterilize the media at 121⁰C for 15 minutes.
Wait until completion of cycle, and collect sterilized media from the autoclave when the chamber temperature reduce at 60⁰C.

Storage of Sterilized culture Media:

After completion of autoclaving activities, transfer all flasks containing the broth media to the test room for use.
Store the agar media at the warming condition (50⁰C) into autoclave until use.
Do not keep the prepared media for more than two weeks [14 days].
Keep the prepared agar plate at (2-8)⁰C into the refrigerator for not more than two weeks.

Handling of Sterilized culture Media:

Ensure the aseptic condition during handle of sterilized media.
Do not de-cap or expose the sterilized media outside Laminar Air Flow or Bio-Safety Cabinet.

Record Keeping:

Keep in practice to Maintain Register for Media Preparation Record, Annexure-I and Annexure-II to keep record for list of media with storage condition and pH limit.

List of Annexure: Download Here

Annexure I Register of Media Preparation

Annexure II List of Media with storage condition and pH Limit

Culture Media preparation in Microbiology Laboratory & its SOP Read More »

Maintenance of ETP [Effluent Treatment Plant]-SOP

Engineering, Facility, Premises and Equipment, SOPs

Maintenance of ETP: This SOP [Maintenance of ETP] will make as per SOP for SOP of the respective company/Organization. Font/line spacing/Margin/Page set up/Header/Footer etc. will change as per requirement of SOP for SOP.

1.0 Purpose:

The purpose of this SOP is to define the standard procedure of preventive maintenance of Effluent Treatment Plant [ETP] of XX Pharmaceuticals Ltd.

2.0 Scope:

This Standard Operating Procedure applies to the Effluent Treatment Plant [ETP] of XX Pharmaceuticals Ltd.

3.0 Definitions/Abbreviation:

ACF: Activated Carbon Filter

ETP: Effluent Treatment Plant

MGF: Multi Grade Filter

PAC: Poly Aluminum Chloride

PPE: Personal Protective Equipment

SOP: Standard Operating Procedure

4.0 Responsibilities:

Engineering Department [Validation]:

Preparing the SOP & revise it when required

Engineering Department [Maintenance]:

To provide essential support for maintenance of the system.

To ensure that the operators are accountable to carry out the maintenance.

Operators

To perform the maintenance activities according to the SOP.

Head of Engineering

To confirm that the maintenance of ETP are done correctly.

Head of Quality Assurance

To ensure overall implementation of this SOP.

5.0 Revision Details

Sl. No./Version No./Effective Date/Change History to be add here

6.0 Annexure:

Annexure has been mentioned in bottom of the document with download link

Annexure-I: Maintenance log sheet of ETP

7.0 Procedure:

7.1 Precautions: All maintenance activities must be done safely in accordance with the necessities of the Plant Safety Declaration and the safety notices from place to place the plant. Specific consideration must be paid to the following:

Handle the chemicals by wearing PPE.
Ensure that the pumps are switched off before initiating any kind of maintenance.

7.2 System Description:

The capacity of ETP is 5000 Liter/hour. The effluents from the production department come into the neutralization and equalization tanks via bar screen chambers. In this bar screen chamber the floating material/solid material is being filtered. A dosing of lime is being delivered in the neutralization tank if pH correction is needed.

The effluents are aerated in this tanks with air which is delivered by the blowers. After being neutralized in the neutralization tank the effluents goes into the equalization tank & then the effluent is relocated to the flocculation tank through effluent transfer pumping system.

A dosing of PAC [Poly Aluminum Chloride] is delivered in the flocculation tank to flocculate all the effluents. Poly electrolyte dosing [PED] is delivered in the transferring pipe of effluents from flocculation tank to the lamella.

After lamella the effluent is passed to the aeration tank. In aeration tank the effluents are aerated with air. A dosing of NaOH[Sodium Hydroxide] is provided if it is required.

There is a buffer tank after the aeration tank where 1kg of urea will be delivered after every Two months of operation. There is a line under the buffer tank to transfer the sludge to underground sludge tank & then to sludge pit by sludge transfer pumping system.

Clear water from the Buffer Tank is stored in the clear water tank. There are two pumps to transfer the clear water to final storage tank through MGF [Multi Grade Filter] & ACF [Activated Carbon Filter]. One pump is used at a time.

7.3 Maintenance Procedure:

7.3.1 Maintenance of ETP will be performed according to the following check list:

Type of maintenance: Daily

Maintenance activities:

Clean the screen bar daily.
Clean the surrounding environment of ETP.

Type of maintenance: Weekly

Maintenance activities:

Clean the control panel.
Check the electrical control panel and electrical connection.

Type of maintenance: After 2 months

Maintenance activities:

Clean the dosing tank.

Type of maintenance: After 3 months

Maintenance activities:

Change the oil of blower/compressor.

Type of maintenance: Yearly

Maintenance activities:

Clean all the tanks
Change the gear oil
Clean the clear water tank

7.3.2 Fill up the log sheet (Annexure-I) after performing preventive maintenance of ETP.

Annexure:

Annexure-I: Maintenance log sheet of ETP

Maintenance of ETP [Effluent Treatment Plant]-SOP Read More »

Breakdown Maintenance SOP for Engineering Department

Breakdown Maintenance, Engineering, SOPs

Breakdown Maintenance: This SOP [Breakdown Maintenance] will make as per SOP for SOP of the respective company/Organization. Font/line spacing/Margin/Page set up/Header/Footer etc. will change as per requirement of SOP for SOP.

1.Purpose

The purpose of this SOP is to define the procedures involved in conducting and handling breakdown maintenance activities of the equipments/machines of XX Pharmaceuticals Limited.

2.Scope

This Standard Operating Procedure applies to all equipments/ machines of GMP all area of XX Pharmaceuticals Ltd.

3.Definitions / Abbreviation:

BM: Breakdown Maintenance
SOP: Standard Operating Procedure
QA: Quality Assurance

4. Responsibilities

The responsibilities are as follows:

Initiating Department:

To inform Quality Assurance, Head of Plant Operations and Engineering Department for the breakdown maintenance of linked equipments, machines or utility rest area.
To fill up the breakdown maintenance memo and backup the carbonated copy.
To put the status label “UNDER MAINTENANCE” on the machine.
To check related machines, equipments or utility services along with Quality Assurance personnel after completion of BM Activities.

Engineering Department/Maintenance Department

To receive the BM Memo and arrange for be present the breakdown maintenance.
To assess the cause of breakdown and resolve the problems.
To oversee the BM job and update necessary record.
To fill up the BM History form for each machine after completion of Breakdown Maintenance.
To preserve the BM related documents.

Technician

To execute the breakdown maintenance by following the appropriate safety precautions

Quality Assurance

To evaluate and select disposition or further operation of products/batches under bearing
To inform Validation Department [Engineering End] to perform requalification or recalibration of the machine/equipment if it is required.
To certify that actionable and recommendation are closed.

Validation Department (at Engineering End)

To perform requalification or recalibration of the equipment/machine if it is necessary.
To issue the Breakdown Maintenance Memo for the individual sections.

Head of Engineering

To monitor actions of engineering personnel who perform the Breakdown Maintenance activities and to provide technical provision and assistance with documentation supplies.
To assessment the history files of equipment’s maintenance annually and at the time of incidence of major failures and to identify the repeated component of failures or other events.
To confirm that the equipment maintenance history files are secured in the Engineering Department.

Head of Quality Assurance

To confirm overall implementation of this SOP

5.Revision Details

Sl. No./ Version No./ Effective Date/ Change History to be add here

6. Procedure

Precautions: All maintenance work must be accomplished safely in agreement with the requirements of the Plant Safety Declaration and the safety notices around the plant. Specific consideration must be paid to the following-

Personal Protective Equipment [PPE] and clothing appropriate to the job must be worn.

Equipment must be electrically inaccessible and locked out where potential.

“Under Maintenance” status label must be attached on the machine during BM activities.

“Shifting in Progress for Maintenance Work” status label must be attached on the machine at the time of shifting for maintenance activities.

6.1 Concerned Department

6.1.1 In case of equipment, machine or utility breakdown, the related departmental personnel will label it with ‘UNDER MAINTENANCE’ status label.

6.1.2 The BM Memo will be a pre-printed, bi-layer, self-carbonated paper which will be filled up by the related departmental personnel and the original copy will be sent to the Engineering Department to evaluate and be present at the problem. The carbonated copy will be store by the relevant department.

6.1.3 The pre-printed serial no. of each page of “BM Memo” will be considered as the “BM Memo” number.

6.2 Quality Assurance Department

6.2.1 Quality Assurance personnel would estimate the breakdown to assess the influence on product quality, safety, efficacy matters and take decision whether the product would be disposed.

6.2.2 Quality Assurance will inform the Validation Team [at Engineering End] after completion of breakdown maintenance to execute the requalification or recalibration of that machine if it is necessary.

6.2.3 Quality Assurance may hold the production batches if any harmful impact occurs till further study.

6.3 Engineering Department

7.3.1 Engineering personnel will receive the “BM Memo” and evaluate the reason and resolve the problems.

6.3.2 Before initiating the maintenance activities, detach unwanted services [‘LOTO Procedure’ to be followed] from the safety point of view.

The breakdown maintenance activities will be carried out according to the equipment handbook (if required) under the supervision of maintenance supervisor/Line In-charge.

6.3.3 A tag “Shifting In Progress For Maintenance” will be put on the machine during shifting to the workshop for maintenance Activities.

6.3.4 After completion of BM activities, relink the utility services and take the usage trial in presence of relevant departmental personnel and Quality Assurance personnel. After successful trial, engineering department will deliver the machine to the relevant department.

6.3.5 Engineering department shall assess the need for requalification or recalibration in discussion with Quality Assurance and document the identical in the memo. Quality Assurance in turn shall inform to production and validation team[at Engineering End] for recalibration or requalification.

6.3.6 Preventive maintenance calendar can be changed based on the rate of breakdown of a specific machine.

6.3.7 Engineering department will maintain the data record of the breakdown activities with trend analysis.

6.3.8 After finishing the breakdown maintenance activities engineering/maintenance person will fill up the “Breakdown Maintenance History Form” of that “Machine/Equipment/System” and store all breakdown related documents in Engineering Department.

6.3.9 If the Area is out of any possible harm and found okay, routine operation will be started after Quality Assurance Inspection with adequate cleaning.

6.3.10 Photocopy of all approved forms will be used. Computer generated copies of all related form can be used with proper note, mentioning in the footer-

‘’This is the computer generated form and similar in that of original form”

8. Annexure [Downloadable File Available]

Annexure-I: Breakdown Maintenance Memo.

Annexure-II: Breakdown Maintenance History form.

This all about the SOP for “Breakdown Maintenance”. This is the basic process and may be change based on company policy [but not limited to].

Breakdown Maintenance SOP for Engineering Department Read More »

Selection and recruitment of Manpower by the HRD[SOP]

SOPs

Selection and recruitment of Manpower: This SOP [Selection and recruitment of Manpower] will make as per SOP for SOP of the respective company/Organization. Font/line spacing/Margin/Page set up/Header/Footer etc. will change as per requirement of SOP for SOP.

1.Purpose

The purpose of this SOP is to lay down the right selection and recruitment of the Manpower as per Approved Requisition From the department through a systemic process.

2.Scope

This SOP is applicable for the all employees of the XX Pharmaceuticals Limited.

3.Definitions / Abbreviation

Selection

Sorting of Curriculum Vitaes (CVs) as per company policy then arrange Written / Oral Examination for the preliminary selected Candidate and finally prepare Merit List based on their interview[Both Written / Oral]. Sending this Merit List to the Managing Director for his valuable comments.

Recruitment

After final review by the Honorable Managing Director, discuss the facility matters with the above Listed Candidates in presence HRD Manager, Hiring Manager & Respective Department Representative [SME, Subject Matter Expert]. When both party end closer to a conclusion, Appointment Letter will be issued with Employment Agreement.

4.Responsibilities:

The roles and responsibilities are as follows:

Executive / Sr. Executive, HR & Admin:

To share the necessary format.

Head of Plant Operation:

To share the necessary format.

To brief the importance of this activity.

To implement this correctly

Head of Quality Assurance:

To approve the SOP

5.Revision Details:

Version No.00

Effective date: 22/05/20XX

Change History: New SOP

6.Annexure

Annexure I- Manpower Requisition Form

Annexure II-Evaluation Sheet for Interviewing Person.

7.Procedure

7.1 Raise the Prerequisite of Manpower by checking its need with proper explanation from the Department Head and needs to be referred to the Head of the HR & Administration as hard copy.

7.2 After receiving, the Head of HR & Administration will forward that prerequisite with a note to the Honorable Managing Director.

7.3 Arrange a circular on the basis of the need duly approved by the Managing Director for the online and offline National/International Media based on company requirement.

7.4 After circulating the prerequisite, collect CVs of multiple applicants on receiving file them accordingly and store them in a proper location.

7.5 After the due date of circular, sorted out all of them and get ready summary list for the commendable candidates, then submitted to the Managing Director for the permission of interview.

7.6 Arrange a formal Interview in the presence of the concern Head of the Department/Designee, related person from cross functional department and the Head of Human Resource/Designee.

7.7 After the completion of interview session, get ready the summary list of the appropriate and overall acceptable candidates with marking (Scale: 0~5). To sum up, submit it to the Managing Director for review and final comments for the next necessary actions.

7.8 Then, Head of HR & Administration/Designee will go for contacting the selected candidate to discuss & finalize the facility issues.

7.9 In conclusion, Head of HR & Administration will take subsequent actions for joining the required personnel on due date.

8.Associate documents

Mention the linked document here

9.References

Mention reference here

This all about the SOP for “Selection and recruitment of Manpower”. This is the basic process and may be change based on company policy [but not limited to].

Download the Annexure Here

Annexure I- Manpower Requisition Form

Annexure II-Evaluation Sheet for Interviewing Person

Selection and recruitment of Manpower by the HRD[SOP] Read More »