Our Products

We offer a complete product range of RUBBER STOPPER STERILIZER, HEATED WATER SPRAY STERILIZER, SOFT GELATIN PLANT, PHARMACEUTICAL INDUSTRY STERILIZERS and Water Systems

Water Systems

We are offering water systems.Over the last 30 years pharmalab has been a leading supplier of plants producing water for injection, which meets international standards, including usp, ip, bp and jp. The plants are manufactured as per fda - current good manufacturing practices (cgmp) and asme requirements and follow the basic principle of distillation by thin film evaporation.

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PHARMACEUTICAL INDUSTRY STERILIZERS

Sterilization (or sterilisation) in simple terms, refers to any process that effectively kills or eliminates transmissible agents (such as bacteria, viruses, sporeforms etc.) from a surface, equipment or biological culture medium. This aspect of sterilisation is critical for the pharmaceutical manufacturing and sterile processing equipment is the cornerstone of the pharmaceutical industry. Every year more pharmaceutical products are recalled for a single reason they fail the Sterility Assurance Test.

Sterilization can be achieved through application of heat, chemicals, irradiation, or filtration. Of these, heat(steam) sterilization is proven to be the most effective.

At Pharmalab India, our sterilizers have been engineered to meet the stringent manufacturing standards, like cGMP, EN285 (European), MHRA (UK), FDA (US), and most of the guidelines being followed by the Pharmaceutical & Bio-tech industries. Pharmalab India believes in Total Qualityand Total Customer Satisfaction, hence manufacturing is in accordance with GAMP & ISO 9001 guidelines & our provision of documentation (Like DQ, QQ, lQ) enables customer to meet the above standards.

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RUBBER STOPPER STERILIZER

Rubber Stoppers (Bungs) are mainly used in stoppering vials and it is necessary tosterilize these as they are in direct contact with the product.Though the trend of using pre-sterilized bungs from the market is still prevalent, their viability is still a question, owing to the various handling & transportation issues leading to questions on sterility.

Pharmalabs unique Bung Processor along with a sterilizer enables customers to reap benefits of twin processes from single machine.The bungs are loaded into a drum and later placed into the sterilizer. The entire operation is done via PLC wherein the pre-set program determines the wash sequence (Eg. Detergent Wash, WFI Wash & Silicon Treatment) followed by a final sterilization using HPHV cycle.This ensures complete sterility for the bungs.These bungs can later be unloaded in sterile pouches/bags and transferred to the filling room, usually under laminar air flow conditions.

Keeping ease of operation in view, Pharmalab has designed a unique drum that has the capability for auto unloading of the bungs, which eliminates the intermediate handling of bungs.Also, with Pharmalabsexpertise you can look forward to special feature like preservative & Hot Air treatment with HEPA Filters for enhanced results.

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HEATED WATER SPRAY STERILIZER

Certain products need to be sterilized in its final container as this permits the measurement and evaluation of quantifiable microbial lethality. This is called terminal sterilization. Terminally sterilized products are treated in a microbially lethal process and hence represent the lowest risk category of sterile pharmaceutical products unlike products aseptically manufactured in a microbiologically controlled environment.

US PHARMACOPEIA GUIDELINES

Terminally sterilized products must have a probability of non-sterility (PNS) of not more than one in a million units produced. This is often stated as PNS of 106, or the probability of product bio-burden surviving the sterilization process in any single unit of product is less than one in one million. The proof that a terminally sterilized product complies with the 106 PNS can be accomplished by several different sterilization cycle development approaches. The proper application of this method requires extensive scientific knowledge regarding the sterilization method selected for use with a specific product.

DESCRIPTION

Super-heated water spray terminal sterilization is an efficient method for achieving sterility with highest assurance of the end product in sealed pharmaceutical containers.

The product is introduced in the sterilizer chamber on appropriate carriages and trays. The chamber bottom is filled with purified water which contains low bio-burden. This water is circulated in a closed loop, utilizing a high quality centrifugal pump. The water passes through an external heat exchanger to reach appropriate sterilization temperature before it is sprayed through perforated distribution plate from the top of the chamber in the cascade form. The elevated flow rate ensures even temperature throughout the chamber during the sterilization process. The water reaches the sterilization temperature quickly. The counter pressure is applied using the sterile filtered air to prevent any damage to plastic container or rubber closures from being displaced from glass bottles. After the sterilization cycle is over, the water is indirectly cooled through the external heat exchanger. The same cooled water remains in circulation resulting in cooling of load in the chamber. The entire sterilization cycle takes approximately 1 hour.

APPLICATIONS

Sterilization of filled containers of HDPE/LDPE bottles, PVC multi-layer pouches or glass bottles.
Terminal sterilization of large volume infusion solution in glass bottles, plastic bags.

FEATURES

High flow circulation centrifugal pumps
Plate type heat exchanger for efficient heating and cooling of water.
Special distribution plate arrangement for optimal water shower
Installation is floor or pit mounted
Optional automatic loading unloading system
Single or double door, semi-automatic hinged type or automatic sliding type
Water distribution headers & spray nozzles arranged in a manner to ensure uniform heat distribution throughout load
Temperature & pressure monitoring inside the chamber
PLC & HMI based control system with provision for SCADA connectivity.
Range of alarms & safety devices for product, process & operator safety
Strip chart or paperless recorders available
High powered centrifugal pump used for re-circulation of water in the system
All international brands piping and valves used to exemplify the performance of the machine (optional)

Also Check Out:

Steam Sterilizer Hinge Door
Rubber Bung Processor Cum Sterilizer
Dry Heat Sterilizer

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SOFT GELATIN PLANT

We design, manufacture and supply Soft Gelatin Plant equipments covering all the process equipments leading up to the point of the encapsulating machine under stringent compliance with latest cGMP norms.

Most important parameters for any Soft Gel Plant which are to be meticulously and articulately incorporated in the design of the process equipments are as follows:

Agitator of Gelatin Cooker is a special kind of Contra-rotating type Anchor having Triangular Blades for imparting low shear mixing action to highly viscous Soft Gelatin mass for intimate mixing.
Hydraulic Lifting System for the top cover of the Gelatin Cooker
PLC Programmed (optional) for Dual speed agitation to reaction mass of Gel cooker as per the defined recipe
Specially constructed Gelatin Feed Tank with electronic heating system
Medicament Mixing & Homogenizing Vessel
Multi-purpose Mixing & De-aeration Unit with SS Control Panel for carrying out the following operation
Mixing of Medicament
Colour Mixing in Gelatin mass
De-aeration of Gel mass
Hydraulic Lifting of Agitators for different operations with quick release coupling for agitator change/cleaning operation
Heat traced transfer pipe line for feeding Gelatin in to the Encapsulating Machine
Vacuum Control System for De-aeration in Gelatin Cooker
Strict compliance to cGMP as per the international standard norms
SS 316L contact parts mirror polished to less than 0.5 Micron RA & SS 304 Non-Contact parts matt finished.
100% drainable, crevice and dead leg free internal surface
CE marked Equipments are offered with Third Party Inspection & All Electrical Control with ERTL Approval & Test

SPECIFICATIONS

Glycerine/ Sorbitol Storage Vessels
Raw Gelatin Feed Tanks
Gelatin Cooker
Gelatin Feed Tanks
Plain/Jacketed Medicament Storage Tanks
Medicament Mixing and Gelatin Colour Mixing and De-aeration Unit with Hydraulic Lift system
Medicament inline Homogenizer & Lobe Pump
SS Working Platform
Instrumentation & Piping
Utility System of Hot Water & Vacuum
Mobile Auto CIP Unit
Gelatin Cooker 100 L to 2000 L Cooker capacity