Pharmaceutical Warehouse

INTRODUCTION:

Ware house is the place where the raw materials, packaging materials and finished products are received, stored and dispatched according to their requirement. Before dispatching, the materials and finished products need to be stored with in an accurately controlled storage environment cGMP validation requirement. This may be achieved by monitoring temperature and humidity sensors continuously

FUNCTION OF WARE HOUSE

1.          Storage of raw and packaging materials.
2.          Temporary storage of finished product before going to control deport storage of rejected materials before disposals.

ACTIVITIES OF WARE HOUSE:

1. Routine works.

2. Periodic works.

Routine works:

a)      Receiving the raw/packaging material and finished products.

b)      Storing these materials in appropriate conditions.

c)      Issuing the raw/packaging material for disposing.

d)      Dispatching finished product

e)      Cleaning the ware house.

Periodic works:

a)      Export of finished goods.

b)      When a new product is launched or product existing price is changed, then warehouse department inform customs department of the government.

DIVISIONS OF WARE HOUSE:

In Drug international Limited ware house is situated on the 1^st floor and ground floor.

They are divided into three categories:

1.      Raw Materials Store (R.M.S)

2.      Packaging materials Store (P.M.S)

3.      Finished product Store (F.P.S)

Raw Materials Store (R.M.S):

Any materials used in the packaging of a product. The term is not only normally extended to cover the outer packaging or delivery cases but also used to the transformation or shipment of the orders.

This is an area where raw materials (API and Excipients) are stored and supplied to the production area after permission of legal authority. In Drug international Limited there are three areas for raw material store:

Area-R1: For excipients e.g. Aerocil 200, Lactose, Sucrose

Area-R2: For API, area is divided for sensitive API e.g. Antibiotics

Area-R3: For API & Excipient of Liquid section e.g. glycerin

Packaging materials Store (P.M.S)

In this area various types of packaging materials are stored. These including:

1. Inners

2. Inserts

3. Shipping carton

4. Cap and spoon for oral liquid

There are four labeling machines in this area and more than 8 workers with an in-charge person

Finished product Store (F.P.S)

The products which are ready for market are known as finished products. This is a large area for storing finished products. The shipping carton of finished products is store in this area.

There are three storage conditions are generally maintained in the ware house-

1. Temperature 15-25°c. The total area for storing packaging materials, raw materials, finished products. The condition is maintained by HVAC system.
2. Temperature 8-15°c. This condition is used to store some raw materials refrigeration is used for this purpose.
3. Temperature 2-8°c.Some Antibiotics & active Pharmaceutical ingredients (API) are stored in this condition.

Pharmaceutical Packing

INTRODUCTION

Packaging can be defined as an economical means of providing presentation, protection, identification information, containment, convenience and compliance for a product during storage, carriage display and use until such time as the product is used or administered. After compression of tablets and coating (if required) the tablets are packed either in blister pack or in the strip.

Packaging area:

There are two types of packaging area:

◈    Primary packaging area

◈    Secondary packaging area

Primary packaging area:

Packaging of solid dosage form is of two types:

v  Stip packaging:

Striping materials are –

ü  Alu-Alu type

ü  PVC- Alu-PVC type

v  Blister packaging:

Blistering materials are-

ü  Alu-Alu type

ü  Alu-PVC type

ü  Alu-PVDC type

Steps of blister packaging:

EQUIPMENTS USED IN PACKAGING AREA:

BLISTER MACHIN – 01

Model: Ministar – V

Capacity: 35X4 =140 strip/min

Max rpm – 38

Set rpm – 35

Current product: Caldil 500mg tab.

Manufacturer: Hoong A Corporation, China

BLISTER MACHIN – 02

Model: Wider – AIII

Buchon machinery Company ltd. Shiheung, Korea

BLISTER MACHIN – 03

Model: Wider – AIII

Capacity: 30X4 =120strip/min

Current product: Dicephin -250ml (I.V)

   Demoxil 250ml (I.M, I.V)

Only use for  powder for injection, ampoule filling

Buchon machinery Company ltd. Shiheung, Korea

BLISTER MACHIN – 04

Model: DPP- 250E1

Capacity: 148strip/min (37X4)

Max rpm –40

Set rpm – 37

Current product: cardizem

ZhejangXinfei machinery company ltd. China

BLISTER MACHIN – 05

Model: Ministar – V

Capacity: 30X4 =120strip/min

Pre heater 150^oc (upper)

Pre heater 150^oc (lower)

Sealer 200^oc

Slitter 100^oc

Hoong A Corporation, China

BLISTER MACHIN – 06

Model: Wider – AIII

Max rpm – 40

Set rpm – 37

Capacity: 120strip/min (30X4)

Buchon machinery Company ltd. Shiheung, Korea

BLISTER MACHIN – 07

Model: DPP- 250E

Capacity: 25 strip/min

Max rpm – 30

Set rpm – 28

Current product: T-cef capsule (200mg)                 

   Cosec capsule (20mg)

ZhejangXinfei machinery company ltd. China

BLISTER MACHINE – 08

Model: DPP- 250E1

Capacity: 180~140strip/ min

Current Product: Clopid 75 mg

                            Diretic 50mg

ZhejangXinfei Machinery Company Ltd. China

BLISTER MACHIN – 09

Model: DPP- 75001

Max rpm – 38

Set rpm – 32

Capacity: 120strip/min (30X4)

Current Product: E-cap 200 mg

ZhejangXinfei machinery company Ltd. China

BLISTER MACHIN – 10

Model: DPP- 75001

Max rpm – 35

Set rpm – 30

Capacity: 120strip/min (30X4)

ZhejangXinfei machinery company Ltd. China

BLISTER MACHIN – 11

Model: DPP- 250E1

Capacity: 100strip/min (25X4)

Current Product: Ulcar 150 mg

Nidocard – retard 2.6 mg

ZhejangXinfei machinery company ltd. China

BLISTER MACHIN – 12

Model: DPP- 75001

Max rpm – 38

Set rpm – 32

Capacity: 120strip/min (30X4)

Current Product: E-cap 200 mg

ZhejangXinfei machinery company ltd. China

Pharmaceutical Semisolid

INTRODUCTION:

Semisolid dosage forms are dermatological products of semisolid consistency and applied to skin for therapeutic or protective action or cosmetic function.

Semisolid dosage forms usually are intended for localized drug delivery. In the past few years, however, these forms also have been explored for the systemic delivery of various drugs. Semisolids constitute a significant proportion of pharmaceutical dosage forms. They can be applied topically to the skin, cornea, rectal tissue, nasal mucosa, vagina, buccal tissue, urethral membrane, and external ear lining.

TYPES OF SEMISOLID DOSAGE FORMS

1. Creams,

2. Ointments

3. Pastes

4. Gels etc.

Cream preparation

Creams are viscous semisolid emulsion system with opaque appearance as contrasted with translucent ointments. Consistency and rheological character depends on weather the cream is w/o or o/w.

• Properly designed O/W creams are elegant drug delivery system, pleasing in both appearance and feel post application.
• O/W creams are non greasy and are rinsable.

They are good for most topical purpose and are considered particularly suited for application to oozing wounds.

Process Flow Chart:

(Fig: Cream manufacturing)

Ointment preparation

Ointments are soft hydrocarbon based semisolid preparation, composed of fluid hydrocarbon meshed in a matrix of higher melting solid hydrocarbon petrolatum being a tasteless, odorless, unctuous material with a melting range. Since they are greasy nature so they stain cloths. Principle ingredients forming the system hydrocarbon and silicon oil are generally poor solvent for most drugs, seemingly setting a low limit on the drug delivery capabilities of the system.  

ENVIRONMENT

Temperature: 20-30⁰ C

Humidity: 30-60 %

DOCUMENTS:

1. Standard Operating Procedure (SOP)

2. Batch Manufacturing Record (BMR)

3. Batch Packaging Record (BPR)

4. In House specification

Automatic Ointment/Cream Manufacturing Plant

  

Process Flow Chart:

(Fig: Ointment manufacturing)

Ophthalmic dosage forms

Ophthalmic dosage forms are preparations designed for application to the eye:

1. For the treatment of diseases

2. For symptomatic relief of symptoms

3. As an aid to surgical procedures

TYPES OF OPHTHALMIC PRODUCT:

Ophthalmic Products may be categorized into a number of groups:

1. Liquid preparations for application to the surface of the eye such as eye drops and eye lotion
2. Semi solid preparations such as eye ointments, creams and gels for application to the margin of the eyelid or for introduction into the conjunctival sac.
3. Solid preparations such as ocular inserts intended to be placed in contact with the surface of the eye to produce modified release of medicament over a prolong period.
4. Parenteral products for subconjuctival or intra ocular injection.
5. Liquid products for irrigation of the eye during surgical procedures.

EYE DROP:

Eye drops are aqueous or oily solutions or suspensions of one or more active ingredients for instillation into the congunctival sac of the eye. These are sterile, free from foreign particles and irritating effects. They are usually buffered and sometimes contains auxiliary substances to adjust the tonicity or viscosity, to increase solubility of the active ingredients or to stabilize the preparations. Aqueous preparations supplied to multi dose containers contain suitable antimicrobial preservatives except when. The preparations itself has adequate antimicrobial properties.

The solubility of a few drugs administered as eye drops is too low to allow their formulations as solutions. In such cases aqueous or oily suspensions are generally prepared. The solid particles must be very fine state of subdivision to prevent irritation of the cornea.

Eye drops have generally been used for administrations of antimicrobial substances like sulfacetamide and gentamicin, anti-inflammatory agent such as corticosteroids, miotics like physostigminesulphate or mydriatic drugs like atropine sulphate. Most drugs used for ophthalmic preparations are weak base or weak acids having poor aqueous solubility. In such cases, their salts such as hydrochlorides, sulphates and nitrates for weakly basic drugs and sodium for weakly acidic drugs are commonly employed.

Eye drops are generally supplied in sealed dropping bottles or sealed bottles along with a dropper. The preparation is meant to be used with in 15 to 30 days of the opening of the seal. These are usually supplied in qualities of not more than 10ml to avoid use over too long a period of time.

ADDITIVES USED IN EYE DROP

1. Vehicle: Water is the most commonly employed vehicle for eye drops formulated as aqueous solutions or suspensions. For oily preparations, vegetable oils such as peanut or sesame oil may be used.

2. Buffers: Human tears normally have a pH of about 7.2 with a good buffering capacity. Unbuffered solution with pH values of between 3.5 and 10.5 can usually be tolerated with little discomfort. Outside this pH range irritation of the eye accompanied by increased lachrymation may occur. Buffers are usually added to adjust the pH to a value that is the best with regard to the solubility or stability of the drug and which will be tolerated by the eye. The buffering agents used in eye drops are borate, phosphate and citrate buffers.

3. Tonicity modifiers: Tonicity modifiers are substances added to eye drops in order to make them isotonic with lachrymal secretions. This is essential because very hypnotic solutions can be cause temporary odema of the cornea resulting in impaired vision where as grossly hypertonic solutions can be cause irritation and discomfort to the sensitive tissue of the eye. Theoretically, eye drops should have a tonicity equivalent to 0.9% solution of sodium chloride. However it has been it has been found the human eyes can tolerate tonicity with a ranger equivalent to between 0.7% and 1.5% of sodium chloride. The most commonly employed agents for the adjustment of tonicity of eye drops is sodium chloride although potassium chloride, glucose, glycerol and buffers can also be used.

4. Stabilizers: A number of drugs used in eye drops are susceptible to oxidation in the presence of air and solutions containing such drugs should included antioxidants to improve their stability. The most common antioxidants used include sodium metasulphite, sodium sulphite, ascorbic acid and acetyl cyysteine. Stability of preparations can also be improved by replacing the air in the bottle by an inert gas such as nitrogen.

ENVIRONMENT:

Dispensing, Processing and Filling area: 100 Class

Other Utility Zone: 1000 Class

Temperature 20-25⁰C

Humidity   30-50%

Process Flow Chart:

(Ophthalmic manufacturing)