Production of small molecules depends on the type of final dosage form be it oral solid dosage form such as tablets or parenteral/injectables. Injectables are further divided into different types of processing from products that can be terminally sterilized to products that need to be aseptically processed. Products which are aseptically processed have a further option if open handling is utilized in ballpark cleanrooms and various grades of Personal Protective Equipment (PPE) and gowning leads towards the aseptic core or where safety doesn’t have to be worn using isolators and other closed handling aseptic and containment systems.
Esco Pharma provides turnkey solutions for potent OSDs <10kg with integrated 3rd party mixers, blenders, fluid bed dryers, granulators.
R&D in academic or industrial labs of potent powders and small molecules can be carried out in various powder coated isolators with BIBO filters (HPI G3, SCI-TE, CBI-T), Flowhoods, Cytotoxic Biological Safety Cabinets, Pharmflow Flowhoods or Powder handling cabinets / VBEs / Fume Cabinets depending on the scale, a typical r&D laboratory will also contain biological safety cabinets, laminar flow cabinets, CO2 incubators.
Primary or Secondary research facilities may often also contain Downflow Booths, Fume Cabinets, benchtop powder handling cabinets/VBEs.
Scaling up for early clinical trials or small batch production can be done in Glassware Hoods/Kilo Labs with integrated chemical reactors to produce kg of powders.
Weighing and Dispensing of potent powder APIs and Excipients can be carried out in our Pharmacon Downflow Booths that can come integrated with Pharmaflow Flowhoods, 1D /2D
These can come in re-circulatory, single pass or combination systems (re-circulatory+single pass) and with or without added personnel, material airlocks and conveyor systems (use solidwork images).
Alternatively if the drums handled are small in size the operator can stand outside the clean area and operate in Pharmaflow Flowhoods with and without gloveports
Closed handling for weighing and dispensing of more potent powders can be carried out in our Weighing and Dispensing Containment Isolators (WDCI).
In event the powders are to be injected into the body, it is becoming more typical for these powders to be weighed in aseptic/potent isolators with BIBO filters such as our Esco Aseptic Containment Isolator (ACTI) which are first bio-decontaminated with Hydrogen Peroxide.
Esco Pharma also provides Ceiling Laminar Airflow (CLAF) or CUAF units over autoclaves and other aseptic processing areas.
These small molecules can then after formulated in aseptic and/potent formulation isolators are ready to be filled in various dosage forms that are either ready-to-use or in traditional filling lines.
As part of formulation of the mother vessel a stainless steel reactor or single use bag connected to a filter can be linked for final filtration of the bulk liquid product before final filling into the drug delivery system.
Esco Pharma provides Filling line isolators, passive or active Open Restrictive Access Barrier Isotaors (oRabs) or Closed Restrictive Barrier Isolator (cRabs) which are integrated with our without freeze/spray driers. Material handling of filling needles and other components, can be performed via laminar flow trolleys to ensure transfer from Grade A to Grade A to Aseptic Core (eg. From partial stoppering after filling in an oRabs or cRabs to freeze drier, or autoclave room to filling isolator)
If aseptic assemblies are to be connected within filling line isolators, isolators integrated with autoclaves can be provided for pre-sterilizing of re-useable filling needles. As an alternative single use filling needles connected to formulation bags in closed liquid transfer systems can be provided. Freeze driers come with manual or auto loading systems, auto stoppering of vials or manual stoppering outside the filling line.
For personnel and material handling, utilizing our Cross-Contamination Facility Integrated Barrier (CCFIB) Misting Showers are provided for operators to prevent cross-contamination during degowning procedures or during emergency situations. Material pass-throughs utilizing either static or dynamic pass-throughs can be utilizing, bringing in of pallets into the central dispensary or warehousing and dedusting of final finished goods can be carried out in dedusting hatches or large air showers to reduce particulates on surfaces of containers.
During small molecule manufacturing various QC/IPQC can be carried out from sterility testing utilizing sterility testing isolators (HPI-G3/CBI-U / GPPI / ACTI) or Biological safety cabinets / Laminar flow Cabinets.
Stability testing of final products need to be carried out at the final packaging site hence Esco Pharma provides stability test chambers of either walk in or mounted within the QC/IPQC Lab.
Final storage of drugs or raw materials may need to be done in cold chain Esco Pharma provides walk in cold rooms.
Enhancing performance of Esco WDCI can be done via integration of other 3rd party additions such as Rapid Transfer Ports (RTP) and Split Butterfly Valve (SBV).
During small molecule production various other process considerations need to be taken into selecting the containment system depending on the OEL/OEB and at terms if powders handled need to be in an Atex Room or just an internal Atex Environment.
As part of growing cGMP requirements within the Pharmacy Compounding and Radiopharmacy space, Esco Pharma was the first to introduce cGMP isolators into the market alongside with our consultation, design & build and validate sister company TaPestle Rx.
As small molecules evolve in requirements and dosage forms Esco Pharma is committed to providing from our core Pharmaceutical technologies a variety of ever growing products and services.
For all our potent products Esco provides in house or working with 3rd surrogate powder testing which involves handling a specific process either during FAT or during IOQ at site.
Esco Downflow Booth Independent 3rd Party Surrogate Powder testing for Egis Hungary.
Esco Pharma continues our services, to our clients of being the commercialization partner to existing Esco Life Sciences customers, translating their research throughout clinical trials and supporting them with custom/bespoke containment systems for their large scale commercial production (needs improvement)