FOOT CARE CREAM

Foot care creams used for healing our feet bear the brunt of our body weight and are constantly exposed to various stressors like tight shoes, long hours of standing, and environmental factors. Neglecting foot care can lead to dryness, calluses, cracked heels, and other uncomfortable conditions. A dedicated foot care routine, including the use of a quality foot care cream, can make a world of difference.

Our feet are unsung heroes, carrying us through the daily grind, yet they often don’t get the attention they deserve. Foot health is crucial, and one way to pamper your feet is through the regular use of foot care cream. The significance of foot care cream, its benefits, and why incorporating it into your self-care routine is a step in the right direction.

Use of Foot Care Cream

Moisturization and Hydration: The skin on our feet is naturally thicker and prone to dryness. Foot care creams are specially formulated with moisturizing ingredients such as shea butter, glycerin, and essential oils. Regular application helps to keep the skin hydrated, preventing issues like dry and flaky skin.

Callus and Corn Reduction: Continuous friction and pressure on certain areas of the feet can lead to the development of calluses and corns. Foot care creams often contain exfoliating agents that help in reducing these rough patches, leaving your feet smoother and more comfortable.

Heel Repair: Cracked heels are a common problem, especially in dry weather. Foot care creams with healing ingredients like urea and lanolin can help repair and soften cracked skin, promoting overall foot health.

Prevention of Fungal Infections: The warm and often damp environment inside shoes can make our feet susceptible to fungal infections. Some foot care creams include antifungal agents like tea tree oil or menthol, helping to prevent and combat such infections.

Relaxation and Massage: Applying foot care cream is not just about nourishing the skin; it’s also an opportunity for a mini massage. Massaging the cream into your feet can improve blood circulation and provide a moment of relaxation after a long day.

Incorporating Foot Care Cream into Your Routine

Daily Application: Make foot care cream a part of your daily routine, especially before bedtime. This allows the cream to work its magic overnight, leaving your feet refreshed in the morning.

Post-Bath Pampering: Applying foot care cream after a warm bath or shower is particularly effective, as the skin is more receptive to moisture.

Choose the Right Product: Select a foot care cream that suits your specific needs. If you have dry and cracked heels, opt for a heel repair cream. For an extra touch of luxury, choose a cream with aromatic essential oils for a soothing experience.

FOOT CARE CREAM: Foot Care Cream eliminates cracked heels and softens rough feet.

Indications:

Cracked heels/soles
Rough feet

Directions for use:
Wash your feet
Pat them dry with a clean towel
Apply foot cream on the affected areas
Use fingertips to massage the cream
Repeat the above steps twice daily.

Use under medical supervision.

PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

PRODUCT NAME: FOOTCARE CREAM

BATCH SIZE: 300 KG,

EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Urea – 10% w/w

Lactic Acid –10% w/w

Propylene Glycol-10% w/w

Liquid Paraffin-10% w/w

EQUIPMENT TO BE USED:

NAME OF EQUIPMENT

Wax Vessel

Water Vessel

Mixing Vessel

Colloidal Mill

Storage Container-I (500 Kg)

Semiautomatic Tube Filling & Sealing Machine

RAW MATERIALS:-

S.NO.	INGREDIENTS	STD	Theoretical Quantity Req.	Overages %	Total Quantity Used
1.	CETO MACROGOL – 1000	I.P.	3.000 KG		3.000 KG
2.	CETOCETYL ALCOHOL	I.P.	6.000 KG		6.000 KG
3	LACTIC ACID	I.P.	30.000 KG	13.34	34.002 KG
4.	LIQUID PARAFFIN LIGHT	I.P.	30.000 KG		30.000 KG
5	METHYLPARABEN (PLAIN)	I.P.	0.300 KG		0.300 KG
6	PEG – 4000	I.P.	103.000 KG		103.000 KG
7	PEG – 400	I.P.	65.000 KG		65.000 KG
8	P.G.	I.P.	30.000 KG		30.000 KG
9	PROPYLPARABEN (PLAIN)	I.P.	0.150 KG		0.150 KG
10	UREA	I.P.	30.000 KG		30.000 KG

PACKING MATERIALS: –

S.NO.	NAME OF THE MATERIAL	THEORETICAL QUANTITY REQ.	TOTAL QUANTITY USED
1.	ADHESIVE TAPE ROLL	1.000	1.000 NOS
2	CELLO TAPE	1.000	1.000 NOS
3	CORRUGATED BOX	33.000	33.000 NOS
4	PLASTIC TUBES	12.000.00	12000.00 NOS
5	UNIT CARTON	12000.000	12003.00 NOS
6	OUTER CARTON	1000.000	1020.00 NOS

MANUFACTURING SPECIFICATIONS:

The average fill of each Tube is 25 grams.

The weight variation limit allowed in each filled Tube is + 200 mg.

Melt the waxes at the maintained temperature of 70˚ C.

Colloid the cream till uniform particle size is achieved.

The temperature of the primary area should not exceed 30˚C.

Yield:

· Theoretical Yield is 12000 Tubes.

· Expected Practical Yield is 12000 + 2% Tube.·

Packing Details:

Transfer the cream from the storage tank to the Semiautomatic Lami Tube Filling & Sealing Machine and start filling and then sealing the tubes as per its SOP.

Pack the filled tubes in unit cartons.

Pack 12 tubes in each outer carton.

Seal the outer carton with cello tape.

Pack the 30 outer cartons in specified corrugated boxes to give a pack size of 30 x 12 x 25g tubes.

Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

Melt 3.0 kg of Ceto Macrogol- 1000, 6.0 kg of Cetocetyl Alcohol, 30 kg of Liquid Paraffin Light, and 103 kg of PEG-4000 in a Steam Heat Wax Melting Vessel by operating it as per its SOP at a temperature of 70˚C.

Heat 20.0 kg of PEG- 400 and transfer it to the mixing vessel after filtering it.

Filter and transfer the melted base through Stainless Steel Sieve no. 100 to the mixing vessel and start the machine.

Heat 3.0 kg of PG to 60˚ C dissolve 0.300 kg of Methyl Paraben and 0.150 kg of Propyl Paraben in it and transfer it to the bulk batch.

Take 34.002kg of Lactic Acid, 45.0 kg of PEG-400, and 27.0kg of PG. Add 30.0kg of urea to it gradually and pass it through the Colloid Mill to achieve the slurry of uniform particle size by operating it as per its SOP and transferring it to the bulk batch.

Cool the cream to room temperature by running the water in the jacket of Mixing Vessel.

Mix the whole batch for 4.5 hours.

Send the sample to the Quality Control Department for bulk testing.

After approval from the Quality Control Department, transfer the cream to the storage tank.

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purposes are all approved materials and have ‘Released’ labels fixed on them.

All weighed Raw materials should be counter-checked by the Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of the Production and QC/QA Manager.

Physical characteristics of Raw materials like colour, odour, and consistency are checked before compounding.

The total weight of bulk ointment / cream should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.

pH of the bulk should be checked and it should be with in specified limits.

Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.

While the tube filling operation is on, the Assistant Manufacturing Chemist should check weight of net filled quantity per tube at the interval of 30 minutes by checking the tare weight of empty tube and gross weight of the filled tube. Record for the same should be kept in Batch Manufacturing Record.

The ‘fill weight’ of ointment or cream per tube should not be less than the labelled amount.

Limit for Weight Variation: Weight claimed on the carton + 200 mg

Manufacturing Chemist will also ensure that the crimping of the filled Aluminum tubes, sealing of plastic tubes is appropriate and embossing of batch number and manufacturing date is conspicuous. Also the quality of embossing will be controlled by adjusting pressure exerted by the jaws, so that pinholes are not developed on the embossed letters / numbers.

The inner and outer cartons should be checked thoroughly for proper batch coding.

Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of inner cartons are being packed in each outer cartons and also the correct number of outer cartons in each shipper is exactly the same as that shown in proof.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

After the completion of filling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned.

Filling or packaging of next product should be commenced only after getting the ‘Line Clearance’ of the previous product, from the IPQA.