Sterility matters across the entire aseptic process – before, during and after sterile filling. Syntegon offers internal and external cleaning machines for vials and other containers. Once the vials have been pre-cleaned with Water for Injection (WFI), our HQL tunnel ensures safe and reliable sterilization and depyrogenation with dry heat.
DetailsThe main steps are: 1. Formulation development. The first step in injectable manufacturing is formulation development. This stage involves extensive research and development to create a stable and effective drug product. Formulation scientists work diligently to identify the appropriate active pharmaceutical ingredients (APIs), excipients, and ...
DetailsThe reconstitution property and time of the lyophilized cake depend on the nature of the diluent (water for injection, 0.9% sodium chloride, 5% dextrose, lactated Ringer's solution) being used for ...
DetailsIn this article we will discuss about manufacturing process. Read: Documentations, Requirements and other formalities to start parenteral dosage form manufacturing company. Parenteral Preparations are the preparations used administration by injections, infusions or implementations into body and directly injected into veins, …
DetailsThis review will focus on the four key aspects of dry pow-der formulation design: the nature of the drug substance, the nature of the particle, formulation approaches and …
DetailsThe dry-powder fill approach involves depositing a drug (plus excipient) into individual vials using suitable filling equipment. The entire process does not involve the addition of …
DetailsIt was concluded that process stands validated for the preparation of dry powder injection because of the content uniformity of the net filled content was found to be in ± 5 % of average net content. In the present work Process validation of Ceftriaxone and Sulbactam as a dry powder injection was carried out. As the manufacturing …
DetailsDry powder inhalers (DPI) are well established products for the delivery of actives via the pulmonary route. ... The DPI manufacturing process heavily involves several particle and powder technologies such as micronization of the API, dry blending, powder filling and other particle engineering processes such as spray drying, …
DetailsIPQC. IPQC means controlling the procedures involved in manufacturing of the dosage forms. starting from raw materials purchase to dispatch of the quality product in ideal packaging. It monitors ...
DetailsA micro-scale 'powder-mixing chip' has been developed that could offer potential advantages over existing mixing technologies in terms of control of product properties and process attributes, and ...
Details3 Inspection Process Flow : 03 3.1 Inspection: Each unit (container closure and its content) of injectable product should be inspected as part of the routine manufacturing process. This inspection should take place at a point when and where defects are most easily detected. Each unit may be examined manually with the unaided …
DetailsA Closer Look at the Freeze-Dry Process • Freezing – Solidify the contents of every vial • Primary drying – Remove, by sublimation, the ice from the frozen matrix. This occurs by bulk flow from a region of higher pressure (the surface of the ice in the product vial) to a region of lower pressure (the chamber). • Secondary drying
DetailsAll the manufacturing units are managed by a team of expert professionals and are hygienic and in a controlled environment. Our processing unit is installed with all the amenities that help us to formulate the Tablets, Capsules, Beta-lactam, Liquid Injectables, Dry Powder Injectibles, and Syrups. Their pharma injection range includes
DetailsOnce this is completed, the injections can be packed and distributed. As you can see, the manufacturing process of injections involves several steps – most of these need to be closely monitored by a human operator to ensure that everything goes well. The process produces both – liquid and Powder Injections rapidly to ensure the healthcare ...
DetailsA model drug, plasmid DNA (pDNA), was stably prepared as a DPI using the spray-freeze-drying process. Under dry conditions, the powders maintained high inhalation characteristics and maintained pDNA integrity for 12 months. The powder induced pDNA expression in mouse lungs that exceeded at higher levels than the solution did.
Detailstechnologies into the drug product. A holistic approach to dry powder product development requires that engineering of the drug substance and particle be performed with consideration of how the formulated powder will be filled, packaged, and ul-timately delivered to a patient's lungs (Fig. 1). What makes formulation of inhaled dry powders …
DetailsA facility for the filling of a sterile dry powder antibiotic is described. The facility comprises the tunnel concept for washing and sterilization of the product containers, a filling unit under laminar airflow with localized vacuum exhaust, a changing room suite, autoclave, airlock, and conventional clean room containing the filling equipment. The need to reduce the …
DetailsAbstract. In the present work Process validation of Ceftriaxone and Sulbactam as a dry powder injection was carried out. As the manufacturing process of dry powder injection is mainly dependent on blending process. In the present investigation, blending process was validated at different speeds of blender and the % assay was estimated by …
DetailsPowder for inhalation is obtained through SFD in two steps. In the first step, nano- or micro-particle suspension is sprayed on the surface or in the bed of liquid nitrogen under a controlled supply of compressed gas ( Figure 5 I,II). The second step involves freeze-drying [ 91, 111] to get dry powder.
Details2). The dry-filling process also is much more cost effective because it requires less infrastructure as well as a reduced amount of energy and a shorter amount of time to produce a batch. (4). These reasons have made dry-filled PIs a popular dosage form. A PI formulation may consist of drug only or drug plus excipient.
DetailsThe FPP are the products of all categories which has undergone all stages of manufacturing process, including packaging in its final container and labelling. The function of In-process quality control is to monitor and if necessary modification and adjustment of the manufacturing process in order to comply with the specifications.
DetailsM/s Keron Life sciences Pvt. Ltd. (KLPL, Selaqui, Dehradun (UK) will start manufacturing of Tablets, Capsules, Ointment, Liquid Oral, Dry Powder, Herbal and Cosmetic & Food only, under orange category in Doon Valley. 1.2 INTRODUCTION History of the Company: KLPL is proposed to be established as an ISO 9001:2000 and WHO- GMP/USFDA certified
DetailsPowders for injection (PIs) are a popular parenteral dosage form for drugs that cannot be marketed as ready-to-use injectables because of their instability in an aqueous …
DetailsDefinitions on Validation. As defined in ICH Q7. -'Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.'(12.40) As defined in ICH Q8(R2)/Q11. Continuous Process Verification.
DetailsThis manuscript will review considerations around the design of an inhaled GDC-A dry powder formulation using a suspension-based spray drying process, with the goal to optimize the physical stability, chemical stability, aerosol performance, pharmacokinetics, and tolerability of a GDC-A drug product. Materials and Methods
DetailsThe process consists of three separate, unique, and interdependent processes; freezing, primary drying (sublimation), and secondary drying (desorption). The advantages of lyophilization include ...
Detailsspecified sterilization process under defined conditions to be used as an indicator for the sterilization cycle efficacy. 2.11 Change control system: A formal system planned and designed to assess all changes that might affect the quality of pharmaceutical product to be intended to ensure the maintenance of process control
Detailssuccessful delivery of dry powder aerosols to the lung requires careful consideration of the powder production process, formulation and inhaler device. The developments and …
DetailsPE series jaw crusher is usually used as primary crusher in quarry production lines, mineral ore crushing plants and powder making plants.
GET QUOTE